A Phase 3 interventional study of Enamel Matrix Derivative application and Saline application in Periodontal Diseases, sponsored by University of Pisa. Status unknown at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of Pisa · Phase 3, Interventional, and Treatment
Periodontal treatment relies on a sequential series of different phases that are usually incapsulated in three main phases: non-surgical treatment, surgical phase and, finally, supportive phase. Whilst, on the one hand not all patients may undergo surgical interventions, on the other hand non-surgical periodontal and supportive treatment are administered to all subjects affected by periodontitis. Both phases are constituted by closed, non-surgical, root instrumentation which is often carried out with similar techniques. Thus, non-surgical periodontal treatment (NSPT) is the one key stone of the treatment of periodontitis.
NSPT is very efficacious. A significant majority of the diseased sites are usually managed non-surgically (Graziani et al., 2017)). Moreover, bleeding on probing and symptoms are significantly decreased by NSPT. Importantly, NSPT is also capable to reduce systemic inflammation (Teeuw et al., 2014), improve glycaemic control (Sanz et al., 2018) and overall ameliorate oral health related quality of life (Graziani, Music, et al., 2019). Lastly, NSPT is cost effective as its costs are moderate and it may be performed by both dentists and hygienists.
Nevertheless, NSPT is often uncapable to solve an entire clinical case and surgical treatment is advocated as in fact the complete closure of the pockets ranges from 57 to 75% according to a follow-up of 3⁄4 months or 6/8 respectively (Solini et al., 2019). Periodontal surgery is also effective, but it is nonetheless a surgical intervention which cannot be defined as deprived of side effects (Graziani et al., 2018).
Thus, in order to improve the outcome of NSPT numerous adjunctive treatment modalities have been advocated (Braun et al., 2008; Graziani et al., 2017; Haffajee et al., 2003). Yet the objective of reducing the need for surgery has been rarely evaluated.
Recently, our group ran a trial in which enamel matrix derivatives (EMD) has been applied as non-surgical adjunct. The findings highlighted that EMD application lowers systemic inflammation, increases blood clot stability and, locally, reduces of the need for surgery by 32% compared to the control group without EMD.
Thus, a multicentre responding to the following questions:
The gel has a suitable viscosity to facilitate application directly onto root surfaces exposed during periodontal surgery. Once applied onto an exposed root surface the protein self assembles into an insoluble three-dimensional matrix and creates a suitable environment for selective periodontal cell migration and attachment, which re-establishes lost tooth supporting tissues. Subsequent to formation of new attachment, alveolar bone can also be regenerated due to the osteogenic capacity of the restored periodontal ligament. EMD is degraded by enzymatic processes of normal wound healing.
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Exclusion Criteria:
Persons with implant-supported restorations affected by peri-implantitis (as defined by the 2017 Classification, i.e. presence of bleeding and/or suppuration on gentle probing, probing depths of ≥6 mm, bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant).
At the completion of the subgingival instrumentation, in all sites with PPD\>6 mm, a solution of 24% EDTA, will be first applied with a sterile syringe with a thin blunt tip (25GX1/4"). The tip will be inserted in the gingival crevice and run apically on the instrumented root taking particular care in not penetrating the underlying soft tissues. The sites will be then copiously rinsed with both water-spray and by 5 sec passage of ultrasonic instrument's fine tip in the site with no contact to the root surface. After irrigation, a thorough drying of the site will be performed with an air-spray and a section of an orthodontic floss will be placed in all sites and left in the site for 1 minute at least. Thus, once Superfloss is removed in the test group, EMD (Emdogain FL®, Institute Straumann AG, Basel, Switzerland) will be applied with a dedicated syringe until overflowing from the pocket border, taking particular care in avoiding trauma to the tissues.
Drug: Enamel Matrix Derivative application
At the completion of the subgingival instrumentation, in all sites with PPD\>5 mm, a solution of 24% EDTA , will be first applied with a sterile syringe with a thin blunt tip (25GX1/4"). The tip will be inserted in the gingival crevice and run apically on the instrumented root taking particular care in not penetrating the underlying soft tissues. The sites will be then copiously rinsed with both water-spray and by 5 sec passage of ultrasonic instrument's fine tip in the site with no contact to the root surface. After irrigation, a thorough drying of the site will be performed with an air-spray and a section of an orthodontic floss will be placed in all sites and left in the site for 1 minute at least. Thus, once Superfloss is removed in the control group, a lavage of sterile saline will be applied with a syringe with a thin blunt tip until overflowing from the pocket border, taking particular care in avoiding trauma to the tissues.
Other: Saline application
in the test group, EMD (Emdogain FL®, Institute Straumann AG, Basel, Switzerland) will be applied with a dedicated syringe until overflowing from the pocket border, taking particular care in avoiding trauma to the tissues.
in the control group, a lavage of sterile saline will be applied with a syringe with a thin blunt tip until overflowing from the pocket border, taking particular care in avoiding trauma to the tissues.
Resolved cases
inter-group differences in % of cases, patient-level analysis, with complete absence of sites with Probing Pocket Depth (PPD) \>=6mm
Time frame: 3, 6 and 12 months after treatment
number of sites with PPD>=6mm
Intra-group and intergroup changes in % and number of sites with PPD\>=6mm. The Probing Pocket Depth (PPD) will be measured as the distance between the gingival margin and the deepest part of the gingival pocket measured through a University of North Carolina -15 periodontal probe (UNC-15) (Hu-Friedy, USA). PPD will be evaluated at 6 sites on each tooth: disto-buccal, buccal, mesio-buccal, disto-lingual, lingual, mesio-lingual. Each measure will be rounded to the nearest millimetre probe.
Time frame: 3, 6 and 12 months after treatment
changes in Full Mouth Plaque Score (FMPS)
intragroup and intergroup change in Full Mouth Plaque Score. The Full Mouth Plaque Score (FMPS) will be measured as the presence or absence of plaque on each tooth surface will be assessed. The bacterial deposits are stained with a plaque-disclosing solution (erythrosine). Areas adjacent to the gingival margins that exhibit an intense staining that can be easily removed with the edge of the probe will be dotted as having plaque. The presence of plaque will be evaluated as 1, while the absence as 0 on 6 areas per tooth (disto-buccal, buccal, mesio- buccal, disto-lingual, lingual, mesio-lingual). A dedicated diagram (see attached medical records, chapter 16) will allow to draw the overall plaque accumulation and mean plaque score will be indicated in percentage (% of sites found positive for the presence of plaque on the total of 6 sites per tooth (O'Leary et al., 1972).
Time frame: 3, 6 and 12 months after treatment
changes in Full Mouth Bleeding Score (FMBS)
intragroup and intergroup change in Full Mouth Bleeding Score. The Full Mouth Bleeding Score (FMBS) will be measured dichotomously after periodontal probing. It will be considered positive when the bleeding occurs after the retraction of the probe (approximate time for evaluation 30 seconds after probe insertion). It will be considered negative when there is no bleeding. The mean bleeding score is indicated in percentage (% of sites detected positive for bleeding on the total 6 sites per tooth )(Ainamo \& Bay, 1975).
Time frame: 3, 6 and 12 months after treatment
mean values of PPD
Intra-group and intergroup changes in terms of full mouth mean values of PPD. The Probing Pocket Depth (PPD) will be measured as the distance between the gingival margin and the deepest part of the gingival pocket measured through a University of North Carolina -15 periodontal probe (UNC-15) (Hu-Friedy, USA). PPD will be evaluated at 6 sites on each tooth: disto-buccal, buccal, mesio-buccal, disto-lingual, lingual, mesio-lingual. Each measure will be rounded to the nearest millimetre probe.
Time frame: 3, 6 and 12 months after treatment
mean values of recession (REC)
Intra-group and intergroup changes in terms of full mouth mean values of REC. The Recession (Rec) will be measured as the distance in mm from the cement-enamel junction (CEJ) to the gingival margin measured through UNC- 15. In the event that CEJ would not be available, one of the following clinical landmarks will be used: crown margin, restored margin, occlusal point.
Time frame: 3, 6 and 12 months after treatment
mean values Clinical Attachment Level (CAL)
Intra-group and intergroup changes in terms of full mouth mean values of CAL. CAL will be calculated as the sum of PPD and REC.
Time frame: 3, 6 and 12 months after treatment
Furcation involvement
Intragroup and intergroup changes in terms of furcations degree. Furcation (FI): furcation involvements will be classified according to horizontal probing with Naber's probe in degree I when the probe can enter the orifice of the furcation, degree II when the probe can enter the furcation freely without passing it completely. Class III will be scored when the tip of the Nabers probe will see appearing through the opposite cervice, i.e. "through-and.through" furcation in both mandibular and maxillary molar (Hamp et al., 1975).
Time frame: 3, 6 and 12 months after treatment
Dentine sensitivity (Schiff test)
Intra-group and intergroup changes of dentine hypersensitivity as measured with the Schiff test. Schiff test: dentine sensitivity will be assessed trough the study timepoints as reported further using a validated a well described test as the Schiff test (Schiff et al., 1994). The Schiff test is a non-invasive and safety test that consist in spraying air on the tooth and collecting the reaction of the patient in a liker type scale as follows: * 0 Subject does not respond to air stimulus; * 1 Subject responds to air stimulus but does not request discontinuation of stimulus; * 2 Subject responds to air stimulus and requests discontinuation of stimulus; * 3 Subject responds to air stimulus, considers stimulus to be painful and requests discontinuation of stimulus.
Time frame: 3, 6 and 12 months after treatment
Oral Health Impact profile 14
Oral Health Index Profile-14 (OHIP-14): a validated questionnaire of 14 question aiming at assessing statements grouped in 7 conceptual subscales: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. It allows an evaluation of the OHRQoL (Slade, 1997). The higher the score, the higher the impact of periodontitis on the patients quality of life
Time frame: 3, 6 and 12 months after treatment
Attention Network Task
Attention Network Task (ANT; Fan et al., 2002): a task designed to test three attentional networks: alerting, orienting, and executive control.The higher the score, the higher the cognitive abilities.
Time frame: 3, 6 and 12 months after treatment
Corsi block-tapping test
Corsi block-tapping test (CBTT; Orsini et al., 1987): a task to assess visuo-spatial short-term memory. The higher the score the better the cognitive ability
Time frame: 3, 6 and 12 months after treatment
Tower of London
Tower of London (ToL; Shallice, 1982): a task designed to evaluate problem-solving and planning capabilities.The higher the score the better the cognitive abilities
Time frame: 3, 6 and 12 months after treatment
Sickness Questionnaire
Sickness Questionnaire ( SicknessQ ; Andreasson et al., 2018): a brief instrument, composed of 10 items, aimed to assess perceived sickness behaviour. The higher the score the higher the perceived thickness
Time frame: 3, 6 and 12 months after treatment
Depression Anxiety Stress Scale
Depression Anxiety Stress Scale - 21 (DASS-21; Lovibond \& Lovibond, 1995): self - report questionnaire designed to assess the symptoms of depression, anxiety and stress. The higher the score the higher the symptoms of depression, anxiety and stress.
Time frame: 3, 6 and 12 months after treatment
State-Trait Anxiety Inventory_ Form
State-Trait Anxiety Inventory\_ Form Y2 ( STAI\_Y2; Spielberger, 1983): self - report questionnaire aimed to investigate trait anxiety that refers to relatively stable individual differences in anxiety proneness, that is, to differences between people in the tendency to perceive stressful situation as dangerous or threatening. The higher the score the higher the tendency os being prone to anxiety.
Time frame: 3, 6 and 12 months after treatment
State-Trait Anxiety Inventory_ Form Y1
State-Trait Anxiety Inventory\_ Form Y1 ( STAI\_Y1; Spielberger, 1983): self - report questionnaire aimed to investigate trait anxiety that refers to a palpable reaction or process taking place at a given time and level of intensity. The higher the score the higher the trait of anxiety assessed.
Time frame: 3, 6 and 12 months after treatment
Profile Mood State
Profile of Mood State (POMS; Grove, Robert \& Prapavessis, 2016): self - report questionnaire aimed to investigate different mood states like.: tension, depression, anger, fatigue, confusion and vigour.
Time frame: 3, 6 and 12 months after treatment
Sleep quality
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989): self-assessment scale that provides a reliable, valid and standardized measure of sleep quality. The higher the score the better the sleep quality
Time frame: 3, 6 and 12 months after treatment
The Insomnia Severity Index
The Insomnia Severity Index (ISI; Morin, 1993): is a self-report questionnaire designed to assess the nature, severity and daytime impact of insomnia. The higher the score the higher the severity of insomnia.
Time frame: 3, 6 and 12 months after treatment
Epworth Sleepiness Scale
Epworth Sleepiness Scale (ESS; Johns, 1991): is a self-assessment tool consisting of 8 items that investigate the general level of daytime sleepiness or the propensity to sleep during different situations of daily life. The higher the score the higher the daily sleepiness.
Time frame: 3, 6 and 12 months after treatment
Plan to share: Undecided
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