An observational study in Peri-implantitis, sponsored by University of Barcelona. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University of Barcelona · Observational
To evaluate longitudinal changes in oral health-related quality of life (OHRQoL) and other patient-reported outcomes (PROMs) throughout the different stages of peri-implantitis therapy, including diagnosis, non-surgical treatment, surgical treatment, and 6-month follow-up. Secondarily, to explore the influence of clinical, implant-related, and surgical factors on patient-reported outcomes and treatment experience.
Prospective multicenter observational cohort study conducted at three university centers: the University of Barcelona (coordinating center), the International University of Catalonia, and the University of Valencia.
Patients diagnosed with peri-implantitis and requiring surgical treatment will be consecutively recruited and followed through four evaluation time points:
T0: Diagnosis T1: Six weeks after non-surgical therapy T2: Six weeks after surgical treatment T3: Six-month follow-up
Primary objective:
To evaluate longitudinal changes in oral health-related quality of life (OHRQoL) throughout peri-implantitis therapy. OHRQoL will be assessed using a modified version of the OHIP-14 questionnaire specifically adapted for patients with peri-implantitis.
Secondary objectives:
To assess changes in patient-reported experience measures (PREMs), including pain, anxiety, emotional impact, satisfaction, functional limitations, aesthetic perception, and treatment expectations.
To investigate the association between patient-reported outcomes and clinical parameters such as probing depth, bleeding/suppuration on probing, peri-implant bone loss, tissue phenotype, and defect morphology.
To evaluate whether patient-reported outcomes differ according to the type of surgical treatment performed (access, resective, regenerative, or combined surgery).
To explore the influence of patient-, implant-, and prosthetic-related factors on treatment experience and quality of life outcomes.
At each study visit, participants will complete the patient-reported outcome questionnaire and undergo standardized clinical assessments. The study does not modify routine clinical care, and all treatments will be provided according to current clinical guidelines and clinician judgment. This study aims to provide novel evidence regarding the real-world patient experience throughout peri-implantitis therapy and to support a more patient-centered approach to peri-implant disease management.
322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.
This study's planned enrollment of 45 is below the median of 83 across 121 observational studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →University of Barcelona is the lead sponsor of 98 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults (≥18 years) diagnosed with peri-implantitis according to the 2017 World Workshop classification who require surgical treatment following non-surgical therapy. Participants will be recruited from the Departments of Periodontology at the Hospital Odontològic Universitat de Barcelona (HOUB), the Clínica Universitària d'Odontologia of the Universitat Internacional de Catalunya (CUO-UIC), and the Universitat de València (UV).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
When previous records are unavailable, implants will be included if they present bleeding and/or suppuration on gentle probing, probing depth ≥6 mm, and a bone level ≥3 mm apical to the most coronal portion of the rough implant surface.
- For patients requiring multiple peri-implantitis surgeries, only the first surgical intervention will be included.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inclusion Criteria Adult patients (≥18 years old) diagnosed with peri-implantitis according to the definition established by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018). Implants presenting bleeding on probing and/or suppuration, increased probing depth, and progressive bone loss compared with previous records. When previous records are unavailable, implants will be included if they present bleeding and/or suppuration on gentle probing, probing depth ≥ 6 mm, and a bone level ≥ 3 mm apical to the most coronal portion of the implant's rough surface. In patients requiring multiple surgical interventions, only the first surgical procedure will be included in the study.
Change in Oral Health-Related Quality of Life (OHRQoL)
Change in oral health-related quality of life throughout peri-implantitis treatment, assessed using the Spanish version of the Oral Health Impact Profile-14 (OHIP-14sp). The total OHIP-14sp score ranges from 0 to 56, with higher scores indicating worse oral health-related quality of life. The outcome will be expressed as the total OHIP-14sp score and compared across the four study time points. Unit of Measure: OHIP-14sp total score (0-56)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment)
Perceived Pain During Each Stage of Treatment (VAS, 0-100 mm)
Pain perceived by the patient during each stage of peri-implantitis treatment, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Anxiety and Concern Related to Diagnosis and Treatment (VAS, 0-100 mm)
Anxiety and concern perceived by the patient in relation to the diagnosis of peri-implantitis and its treatment, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no anxiety or concern and 100 indicates the highest imaginable level of anxiety or concern. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Emotional Impact of Peri-Implantitis (VAS, 0-100 mm)
Emotional impact perceived by the patient in relation to the diagnosis of peri-implantitis and its treatment, including feelings such as fear of implant loss and frustration with the diagnosis, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no emotional impact and 100 indicates the highest imaginable emotional impact. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Satisfaction with Treatment Received (VAS, 0-100 mm)
Patient satisfaction with the treatment received for peri-implantitis, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no satisfaction and 100 indicates the highest possible level of satisfaction. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Perceived Oral Function (VAS, 0-100 mm)
Patient-perceived oral function following peri-implantitis treatment, including the ability to chew, speak, and perform oral hygiene, measured using a 100-mm visual analogue scale (VAS), where 0 indicates complete functional impairment and 100 indicates normal oral function. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Perceived Treatment Outcomes Compared with Expectations (VAS, 0-100 mm)
Patient perception of the extent to which the outcomes of peri-implantitis treatment met their initial expectations, measured using a 100-mm visual analogue scale (VAS), where 0 indicates that the treatment outcomes did not meet expectations at all and 100 indicates that the treatment outcomes completely met or exceeded expectations. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Perceived Aesthetic Outcome Following Surgical Treatment (VAS, 0-100 mm)
Patient perception of the aesthetic outcome following surgical treatment for peri-implantitis, measured using a 100-mm visual analogue scale (VAS), where 0 indicates complete dissatisfaction with the aesthetic outcome and 100 indicates complete satisfaction with the aesthetic outcome. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)
Probing Depth (PPD, mm)
Depth of peri-implant sulcus measured at six sites per implant using standardized probing force (20-25 g). Unit of Measure: millimeters (mm)
Time frame: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Radiographic Marginal Bone Level (mm)
Radiographic marginal bone level measured in millimeters as the distance from the implant reference point designed to be in intimate contact with the bone to the most coronal bone-to-implant contact on standardized periapical radiographs. Unit of Measure: Millimeters (mm)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Peri-Implant Bone Defect Configuration
Peri-implant bone defect morphology classified according to the predominant defect configuration as intrabony, suprabony, or combined, based on the intraoperative clinical assessment. Unit of Measure: Categorical (intrabony, suprabony, combined)
Time frame: T2 (during surgical treatment).
Width of Keratinized Mucosa (KM, mm)
Distance from the mucosal margin to the mucogingival junction at the buccal aspect of the implant, measured using a periodontal probe. Unit of Measure: Millimeters (mm)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Thickness of Keratinized Peri-Implant Mucosa
Thickness of the buccal keratinized peri-implant mucosa assessed using the periodontal probe transparency method. The mucosa is classified as thin if the periodontal probe is visible through the tissue (\<1 mm) and thick if the probe is not visible (≥1 mm). Unit of Measure: Categorical (thin \[\<1 mm\] or thick \[≥1 mm\])
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Age
Participant age at baseline (T0), calculated as the interval between the date of birth and the enrollment date. Unit of Measure: Years, months, and days
Time frame: T0 (baseline)
Sex
Self-reported sex of the participant, recorded at baseline. Unit of Measure: Categorical (Male, Female, Other, Prefer not to disclose)
Time frame: Time Frame: T0 (baseline)
Smoking Status
Self-reported smoking status at baseline. Unit of Measure: Categorical (Never smoker, Former smoker, Current smoker)
Time frame: T0 (baseline)
Cigarettes Smoked per Day
Average number of cigarettes smoked per day, self-reported by current and former smokers. Unit of Measure: Cigarettes/day
Time frame: T0 (baseline)
Relevant Systemic Comorbidities
Presence of relevant systemic comorbidities based on the participant's self-reported medical history and clinical records. Unit of Measure: Categorical (Yes/No)
Time frame: T0 (baseline)
Toothbrushing Frequency
Self-reported frequency of toothbrushing. Unit of Measure: Categorical (Once daily, Twice daily, Three or more times daily)
Time frame: T0 (baseline)
Toothbrush Type
Type of toothbrush routinely used by the participant. Unit of Measure: Categorical (Manual, Electric, Both)
Time frame: T0 (baseline)
Interproximal Cleaning Method
Primary method used by the participant for interproximal oral hygiene. Unit of Measure: Categorical (Dental floss, Interdental brushes, Oral irrigator, None)
Time frame: T0 (baseline)
Frequency of Interproximal Cleaning
Self-reported frequency of interproximal oral hygiene. Unit of Measure: Categorical (Never, Occasionally, Daily)
Time frame: T0 (baseline)
Reason for Previous Tooth Loss
Primary reason for the loss of the tooth replaced by the implant, based on the participant's dental history and clinical records. Unit of Measure: Categorical (Periodontitis, Caries, Endodontic failure, Root fracture, Trauma, Congenital absence, Orthodontic extraction, Other)
Time frame: T0 (baseline)
Dental Arch
Arch in which the implant is located. Unit of Measure: Categorical (Maxilla, Mandible)
Time frame: T0 (baseline)
Implant Position
Anatomical position of the implant according to its location in the dental arch. Unit of Measure: Categorical (Anterior, Posterior)
Time frame: T0 (baseline)
Specific Implant Site
Specific tooth position replaced by the implant, recorded using the FDI tooth numbering system. Unit of Measure: Tooth number
Time frame: T0 (baseline)
Implant Brand
Commercial brand of the implant. Unit of Measure: Free text
Time frame: T0 (baseline)
Implant Model
Commercial model of the implant. Unit of Measure: Free text
Time frame: T0 (baseline)
Implant Surface
Type of implant surface according to the manufacturer's specifications. Unit of Measure: Categorical (Treated, Untreated)
Time frame: T0 (baseline)
Prosthetic Connection Type
Type of implant-prosthetic connection. Unit of Measure: Categorical (Internal, External, Conical, Other)
Time frame: T0 (baseline)
Restoration Retention Type
Type of implant-supported restoration according to its retention mechanism. Unit of Measure: Categorical (Screw-retained, Cement-retained)
Time frame: T0 (baseline)
Year of Prosthetic Loading
Calendar year in which the implant-supported prosthetic restoration was delivered and functionally loaded. Unit of Measure: Year
Time frame: T0 (baseline)
Total Number of Implants per Patient
Total number of dental implants present in the participant at baseline, recorded to account for patient-level clustering in statistical analyses. Unit of Measure: Number of implants
Time frame: T0 (baseline)
Year of Implant Placement
Calendar year in which the implant was surgically placed. Unit of Measure: Year
Time frame: T0 (baseline)
Bleeding and/or Suppuration on Probing (BoP/SoP)
Presence of bleeding and/or suppuration elicited within 30 seconds after gentle probing at six sites per implant using a standardized periodontal probe. Unit of Measure: Categorical (Present/Absent)
Time frame: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Type of Surgical Procedure
Surgical approach used for the treatment of peri-implantitis, classified according to the primary surgical technique performed. Unit of Measure: Categorical (Access surgery, Resective surgery, Regenerative surgery, Combined surgery)
Time frame: T2 (during surgical treatment)
Postoperative Wound Dehiscence
Presence of postoperative wound dehiscence at the surgical site, assessed during the postoperative clinical examination. Unit of Measure: Categorical (Present/Absent)
Time frame: T2 (6 weeks after surgical treatment)
Postoperative Complications
Occurrence of postoperative complications related to peri-implantitis surgery, including the type of complication when present. Unit of Measure: Categorical (Absent/Present) and free text (type of complication)
Time frame: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 33 non-industry observational studies under Peri-Implantitis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 77. This study's planned 12 months is below that.
Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Barcelona