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Evaluation of Volume Stable Collagen Matrix in the Regenerative Outcome of Periodontal Intrabony Defects

NCT05569473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-27

No results posted yet for this study

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.

Conditions

  • Intrabony Periodontal Defect

Interventions

PROCEDURE

TEST GROUP: VCMX + OFD, CONTROL GROUP : OFD ONLY

A full-thickness mucoperiosteal flap will be raised, no bone recontouring would be performed, Thorough debridement of the surgical site would be performed. For the test group, VCMX would be placed according to the dimensions of the intrabony defect after open flap debridement (OFD). For the control group, OFD will be done and After this, flaps would be approximated and sutured at the original position with a monofilament suture material using interrupted sutures.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • Pratiksha Chordiya, MDS · Postgraduate Institute of Dental Sciences Rohtak

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-01-28
Completion
2024-01-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569473 on ClinicalTrials.gov