Guided Tissue Regeneration, Intrabony Defects, Periodontal Diseases
Conditions
Keywords
resorbable collagen membrane
Brief summary
This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.
Interventions
Use of resorbable collagen membrane to treat periodontal intrabony defects.
Sponsors
Collagen Matrix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 65 years, male or female; 2. patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999; 3. Only solitary lesion site requires surgical treatment and must meet the following criteria: 1. The baseline PD≥7 mm ; 2. After debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected; 3. The wideness of the keratinized gingiva≥2 mm; 4. Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm;
Exclusion criteria
1. The test tooth has open surgical debridement history within the most recent one years; 2. Known allergy to collagen of animal origin; 3. Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of CAL at 12 weeks after surgery | 12 weeks | Assessment of clinical attachment level |
| The change of CAL at 24 weeks after surgery | 24 weeks | Assessment of clinical attachment level |
| The change of PD at 12 weeks after surgery | 12 weeks | Assessment of Probing Depth |
| The change of PD at 24 weeks after surgery | 24 weeks | Assessment of Probing Depth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery. | 12 weeks | Effect on Gingival recession |
| The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery. | 24 weeks | Effect on Gingival recession |
Countries
China
Outcome results
None listed