Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease
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|ClinicalTrials.gov Identifier: NCT03671512|
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Periodontal Diseases||Device: Periodontal Structure Repair (PSR) Device: Standard Root Planing||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||A Phase III, Prospective, Randomized, Active Comparator-controlled, Parallel Group, Subject-paired Study Comparing Standard Root Planing vs. a Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease.|
|Actual Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Periodontal Structure Repair (PSR)
Periodontal pockets treated with PSR
Device: Periodontal Structure Repair (PSR)
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.
Active Comparator: Standard Root Planing (SRP)
Periodontal pockets treated with SRP
Device: Standard Root Planing
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 periodontal pocket depth compared to standard root planing at 8 weeks [ Time Frame: 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.
- Change in periodontal pocket depth compared to standard root planing at 12 and 16 weeks [ Time Frame: 12 weeks 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.
- Change in clinical attachment level compared to standard root planing at 8 weeks [ Time Frame: 8 weeks ]The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
- 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 at 8 weeks. root planing [ Time Frame: 8 weeks ]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
- 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 at 8 weeks [ Time Frame: 8 weeks ]The gingival margin level measurements to be performed: buccal mesial, buccal, buccal distal, lingual mesial, lingual, lingual distal.
- Degree of inflammation following procedure [ Time Frame: 8 weeks ]
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.
- Degree of erythema following procedure [ Time Frame: 8 weeks ]
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.
- Presence or absence of bleeding on probing following procedure [ Time Frame: 8 weeks ]Bleeding on probing will be reported by a yes/no response
- Degree of infection following procedure [ Time Frame: 8 weeks ]Presence of gingival infection will be recorded by a yes/no response
- Degree of pain following procedure [ Time Frame: 8 weeks ]Measured by the Pain Quality Assessment Scale (PQAS). Nineteen pain qualities are assessed on scales of 0 to 10,with zero being not pain and 10 being the most pain imaginable.
- Degree of swelling following procedure [ Time Frame: 8 weeks ]
Gingival swelling will be measured using the Sulcus Bleeding Index (SBI)
- Score 0 - healthy looking gingiva no bleeding on probing:
- Score 1 - healthy looking gingiva, bleeding on probing;
- Score 2 - bleeding on probing, change in color, no edema;
- Score 3 - bleeding on probing, change in color, slight edema;
- Score 4 -bleeding on probing, change in color, obvious edema;
- Score 5 -spontaneous bleeding, change in color, marked edema
- Tooth mobility of PSR-treated teeth versus standard root planing [ Time Frame: 8 weeks ]
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
- Safety profile of the PSR procedure versus standard root planing for management of periodontal pocket disease up to 16 weeks [ Time Frame: 16 weeks ]Related adverse events will be described and recorded for both treatment arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671512
|Contact: Robert Michelemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham School of Dentistry||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Nicolaas Geurs, DDS 205-934-1074 firstname.lastname@example.org|
|United States, New York|
|Stony Brook School of Dental Medicine||Recruiting|
|Stony Brook, New York, United States, 11794-8703|
|Contact: Srinivas Myneni, DDS 631-632-8739 SrinivasRao.MyneniVenkatasatya@stonybrook.edu|
|United States, North Carolina|
|University of North Carolina at Chapel Hill School of Dentistry||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Christiano Susin, DDS 919-537-3727 email@example.com|
|Study Chair:||Michael Fare||Periovance, Inc|