This study evaluates the efficacy and safety of Periodontal Structure Repair device (PSR) compared to conventional periodontal therapy (scaling and root planing) for the treatment of periodontal pockets caused by periodontal disease.
This is a multicenter, prospective, randomized, open, active comparator-controlled study with a parallel group, subject-paired design (i.e. the effect of both treatments can be observed in the same subject). Subjects must have two quadrants of their mouth that each have at least two teeth with one or more pockets per tooth that are 5-8 mm in depth. Subjects having more than 2 quadrants will have the first 2 quadrants randomized to receive two different treatments (one quadrant root planing and one quadrant PSR procedure) from the group of available quadrants. Investigators will assess the efficacy of the Periodontal Structure Repair device (PSR) as measured by a reduction in pocket depth.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally.
Ultrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned.
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, United States
Forsyth Institute
Cambridge, Massachusetts, United States
Stony Brook School of Dental Medicine
Stony Brook, New York, United States
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States
Change in periodontal pocket depth compared to standard root planing at 8 weeks
The pocket depth is measured using a Williams' periodontal probe. The probe is inserted into the pocket until resistance is met. The depth of the pocket is measured in millimeters (mm) indicated on the probe. Measure the distance from the gingival margin to the tip of the periodontal probe. Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Time frame: 8 weeks
An acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of select adverse events
The primary safety endpoints are to demonstrate an acceptable safety profile at Visit Week 8 as evidenced by no clinically significant increase in the occurrence of any of the following adverse events for the PSR-treated pockets versus the current standard of treatment for periodontal pockets (scaling and root planing): 1. an increase in pocket depth ≥ 2 mm 2. clinical signs and symptoms of an abscess 3. pain localized to the treated teeth.
Time frame: 8 weeks
Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks
The pocket depth is measured using a Williams' periodontal probe. Each pocket will have six measurements taken around the tooth at the following locations: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Time frame: 12 weeks and 16 weeks
Change in clinical attachment level compared to standard root planing at Visit Weeks 4, 8, 12 and 16
The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Time frame: 4, 8, 12, 16 weeks
To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for pocket depth reduction for PSR-treated versus root-planed teeth.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Each pocket will have six measurement taken around the tooth. The pocket depth measurements to be performed include: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal
Time frame: 4, 8, 12, 16 weeks
To evaluate the percentage of subjects who achieve 15% and 25% improvements over baseline for clinical attachment level for PSR-treated versus root-planed teeth
The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
Time frame: 4, 8, 12, 16 weeks
Degree of inflammation following procedure
Inflammation measured the Gingival Index (Löe and Silness, 1963). * 0 = Normal gingiva * 1 = Mild inflammation: slight change in color, slight edema. No bleeding on probing. * 2 = Moderate inflammation: redness, edema, and glazing. Bleeding on probing. * 3 = Severe inflammation: marked redness and edema. Ulceration. Tendency for spontaneous bleeding.
Time frame: 8 weeks
Degree of erythema following procedure
Gingival erythema - measured using the Modified Gingival Index (MGI) (Lobene et al. 1986) * 0 = absence of inflammation; * 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; * 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; * 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; * 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.
Time frame: 8 weeks
Presence or absence of bleeding on probing following procedure
Bleeding on probing will be reported by a yes/no response
Time frame: 8 weeks
Degree of Pain using the Pain Quality Assessment Scale (PQAS), National Initiative on Pain Control™ (NIPC).
The scoring system will be used to grade the amount of pain felt by the subject in their mouth and jaw areas where the scaling and root planing or PSR treatment was performed.
Time frame: 8 weeks
Gingival Infection: Presence of gingival infection
Presence of gingival infection will be recorded by a yes/no response in the case report form. If infection is present, the quadrant of the mouth will be recorded.
Time frame: 8 weeks
Sensitivity
Subjects will be asked by the examining dental professional if they have experienced any temperature-related pain or discomfort in their teeth or gums.
Time frame: 8 weeks
Tooth mobility of PSR-treated teeth versus standard root planing
Tooth mobility will be assessed using the Tooth Mobility Scale (Miller, 1985) * Class 1: \<1mm (horizontal) movement of the tooth * Class 2: \>1mm (horizontal) movement of the tooth * Class 3: \>1mm (horizontal and vertical mobility) of the tooth
Time frame: 8 weeks
Safety profile of the PSR procedure versus standard root planing for management of periodontal pocket disease through Visit Week 16.
The full safety profile will be assessed by the following: 1. Evaluate the adverse event (AE) safety profile of the PSR procedure versus STA for the management of periodontal pocket disease through the trial. 2. Evaluate blood laboratory values at Baseline, Visit Week 12 and Visit Week 16. 3. To evaluate the pocket depth effect of the PSR device and procedure versus STA over time (including 8 week, 12 week and 16 week assessments) utilizing a longitudinal analysis approach.
Time frame: 16 weeks