An interventional study of Chlorhexidine and Placebo in Peri-implant Mucositis, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2018-05-23.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis.
Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse
Other: Chlorhexidine
Mechanical treatment + Placebo mouth rinse
Other: Placebo
0.03% Chlorhexidine + 0.05% CPC mouth rinse
Placebo mouth rinse
Change on bleeding on probing on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. Primary outcome would be considered for the change between baseline and 12 months One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time frame: Change baseline-12 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time frame: Baseline
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time frame: 3 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time frame: 6 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time frame: 9 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time frame: 12 months
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: Baseline
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 6 months
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 12 months
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): * Score 0: no plaque detected; * Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; * Score 2: plaque can be seen by the naked eye; * Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Time frame: Baseline
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): * Score 0: no plaque detected; * Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; * Score 2: plaque can be seen by the naked eye; * Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Time frame: 6 months
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): * Score 0: no plaque detected; * Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; * Score 2: plaque can be seen by the naked eye; * Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Time frame: 12 months
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth * Score 0: no plaque detected; * Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth * Score 2: plaque can be seen by the naked eye; * Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: Baseline
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth * Score 0: no plaque detected; * Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth * Score 2: plaque can be seen by the naked eye; * Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 6 months
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth * Score 0: no plaque detected; * Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth * Score 2: plaque can be seen by the naked eye; * Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 12 months
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Time frame: Baseline
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Time frame: 6 months
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Time frame: 12 months
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: Baseline
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 6 months
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 12 months
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Time frame: Baseline
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Time frame: 6 months
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Time frame: 12 months
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: Baseline
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 6 months
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time frame: 12 months
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed \& Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Time frame: Baseline
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed \& Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Time frame: 6 months
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed \& Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Time frame: 12 months
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Time frame: Baseline
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Time frame: 6 months
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Time frame: 12 months
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Time frame: Baseline
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Time frame: 6 months
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Time frame: 12 months
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Time frame: Baseline
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Time frame: 3 months
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Time frame: 12 months
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Time frame: Baseline
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Time frame: 6 months
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Time frame: 12 months
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Time frame: Baseline
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Time frame: 6 months
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Time frame: 12 months
Plan to share: No
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Universidad Complutense de Madrid