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

NCT05569473 | Completed DMC

• 1 other identifier: Pratiksha PGIDS/BHRC/22/30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• BONE FILL PERCENTAGE(BF%)

  bone fill percentage will be recorded pre op and post op.

  9 MONTHS

Study Arms (2)

Test group

EXPERIMENTAL

Intrabony defect filled with VCMX after along with open flap debridement \[OFD+VCMX\])

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

control group

EXPERIMENTAL

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.

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

Interventions

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

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.

Test group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

Study Officials

• Pratiksha Chordiya, MDS

  Postgraduate Institute of Dental Sciences Rohtak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 1, 2022
• Primary Completion: January 28, 2024
• Study Completion: January 28, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)