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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal Structure Repair (PSR) | Experimental | Periodontal pockets treated with PSR |
|
| Standard Root Planing (SRP) | Active Comparator | Periodontal pockets treated with SRP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal Structure Repair (PSR) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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):
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks and 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fare | Periovance, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Dentistry | Birmingham | Alabama | 35294 | United States | ||
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For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.
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The assessments of efficacy measurements of pocket depth and attachment gain CAL will be performed by a dental professional staff member at the investigator site who is blinded to which procedure was performed in each quadrant. Whenever possible, the same staff member will make these assessments throughout the study. The pocket depth assessments will be performed by a dental professional who has been trained on the actual method. Personnel will be trained to use the University of North Carolina (UNC) probe by the central trainer provided by the sponsor or CRO.
|
| Standard Root Planing | Device | 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. |
|
| 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. | 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. | 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 | 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. | 4, 8, 12, 16 weeks |
| Degree of inflammation following procedure | Inflammation measured the Gingival Index (Löe and Silness, 1963).
| 8 weeks |
| Degree of erythema following procedure | Gingival erythema - measured using the Modified Gingival Index (MGI) (Lobene et al. 1986)
| 8 weeks |
| Presence or absence of bleeding on probing following procedure | Bleeding on probing will be reported by a yes/no response | 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. | 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. | 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. | 8 weeks |
| Tooth mobility of PSR-treated teeth versus standard root planing | Tooth mobility will be assessed using the Tooth Mobility Scale (Miller, 1985)
| 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:
| 16 weeks |
| Forsyth Institute |
| Cambridge |
| Massachusetts |
| 02142 |
| United States |
| Stony Brook School of Dental Medicine | Stony Brook | New York | 11794-8703 | United States |
| University of North Carolina at Chapel Hill School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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