Intrabony Periodontal Defect Clinical Trial
Official title:
Clinical and Radiographic Evaluation of Volume Stable Collagen Matrix (VCMX) in the Regenerative Outcome of Periodontal Intrabony Defects in Humans: A Randomized Controlled Clinical Trial."
Periodontal intrabony defect is a specific osseous defect with definite morphology. Numerous therapeutic modalities for restoring such defects have been investigated. Nanocomposites and nanostructured materials are thought to have a key function in hard tissue research, since natural bone tissue is a distinctive model of a nanocomposite. Collagen has been potentially used in periodontal tissue engineering. The integration of collagen as a structural protein, serving as an essential component of connective tissue into three-dimensional scaffolds implanted after periodontal injury, necrosis or inflammation has attracted much attention in tissue regeneration. If a collagen matrix collapses after implantation, host cell migration and blood vessel penetration may be impaired, which in turn negatively influences tissue degradation and integration as well as extracellular matrix production in the interior of the biomaterial. Thus, volume stability is an important parameter for tissue augmentation. Volume stable collagen matrix (VCMX) is able to overcome the volume stability limitation of most commercially available grafts.7 It is one of the most biocompatible, novel material to be used in this study. It will be the first time that VCMX is to be used to regenerate the periodontal tissues in intrabony defects in humans.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Two-, three-, or combined two/three-wall intrabony defects with depth = 3 mm (initially analyzed by transgingival probing and intraoral periapical radiographs and confirmed after flap elevation) - PPD = 5 mm - CAL = 3 mm - tooth mobility < grade 1 - experimental teeth and adjacent teeth would be required to be vital and free of caries or dental restorations. Exclusion Criteria: - Any systemic illness that could affect the periodontium or outcome of periodontal therapy - patients on medications such as corticosteroids or calcium channel blockers - long-term nonsteroidal anti-inflammatory drug therapy - pregnant or lactating women - current and past smoker - Periodontitis stage 4 - teeth with one-wall defect, the presence of exostoses and ledges, grade II and grade III mobile teeth, defects extending to a root furcation area, unrestorable teeth, fractured/perforated roots, developing permanent teeth, endodontically treated teeth, and teeth with premature contact and dental prosthesis. |
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Dental Science | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Probing depth (PD) | probing depth will be measured as the distance from the gingival margin to the base of pocket the probing depth. Measurements will be assessed using a calibrated manual periodontal probe (PCP UNC-15 Hu friedy Chicago, IL, USA. The probe will be inserted in the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of a tooth mesio buccal, mid buccal, distobuccal, mesio lingual, mid lingual and distolingual measurements will be rounded to the nearest whole mm. | 9 MONTHS | |
Primary | Clinical attachment level (CAL) | clinical attachment level will be measured at the distance between the base of the pocket and the cement enamel junction (CEJ). Measurements will be made at 6 sites of each tooth - mesiobuccal, mid buccal, disto buccal, mesio lingual, mid lingual and distolingual using UNC 15 probe. | 9 MONTHS | |
Primary | BONE FILL PERCENTAGE(BF%) | bone fill percentage will be recorded pre op and post op. | 9 MONTHS |
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