Evaluation of Volume Stable Collagen Matrix in the Regenerative Outcome of Periodontal Intrabony … (NCT05569473) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Volume Stable Collagen Matrix in the Regenerative Outcome of Periodontal Intrabony Defects
India40 participantsStarted 2022-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Probing depth (PD)
Timeframe: 9 MONTHS
2
Clinical attachment level (CAL)
Timeframe: 9 MONTHS
3
BONE FILL PERCENTAGE(BF%)
Timeframe: 9 MONTHS
Trial details
NCT IDNCT05569473
SponsorPostgraduate Institute of Dental Sciences Rohtak