Efficacy of Volume Stable Collagen Matrix in Interdental Papilla Reconstruction in Maxillary Esthetic Region

NCT05576441 | Unknown DMC

• 1 other identifier: Geetanjali Sharma
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

: Interdental papilla deficiency leads to food impaction, problems with phonetics and an unaesthetic appearance. Reconstruction of the deficient papilla is therefore, important. The purpose of study is to compare the VCMX and SCTG in papillae reconstruction. The null hypothesis is that there is no significant difference in clinical outcome for interdental papilla regeneration by volume stable collagen matrix and subepithelial connective tissue graft.

Conditions

Gingival Recession Localized Moderate

Keywords

Interdental papilla reconstruction

Outcome Measures

Primary Outcomes (1)

• Gain in papillary height

  distance measured from tip of papilla to an imaginary line connecting most apical point of gingival zenith of adjacent teeth will be measured in mm.

  6 months

Study Arms (2)

test group: VCMX

EXPERIMENTAL

Volume stable collagen matrix will be placed at recipient site and suturing will be done with a 5-0 vicryl suture.

Procedure: volume stable collagen matrix

Control group:SCTG

EXPERIMENTAL

SCTG will be harvested from donor site as per the requirement and will be placed at the recipient and suturing will be done with 5-0 vicryl suture.

Procedure: subepithelial connective tissue graft

Interventions

volume stable collagen matrix PROCEDURE

Volume stable collagen matrix will be placed at recipient site and suturing will be done with a 5-0 vicryl suture.

test group: VCMX

subepithelial connective tissue graft PROCEDURE

SCTG will be harvested from donor site as per the requirement and will be placed at the recipient and suturing will be done with 5-0 vicryl suture.

Control group:SCTG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in the age range of 18-55 years who are systemically healthy.
• Patients with class II papillary recession according to Norland and Tarnow's classification and radiographically,the distance between contact point(CP) to alveolar crest ≤ 6mm.
• Patients who have completed etiological periodontal therapy(full mouth scaling and root planning)with Plaque index(Silness and Loe)\<1,gingival index(Loe and silness)\<1 and showing adequate compliance and willing to participate in the study.
• Patient complains of food lodgement or esthetic consideration for open gingival embrasure

You may not qualify if:

• Patients with the history of uncontrolled hypertension, diabetes,hyperthyroidism and on medications that influence the outcome of periodontal therapy.
• Presence of open contacts in the maxillary anterior region.
• Presence of crowding in the maxillary anterior region.
• Pregnant and lactating women.
• Patients with active periodontal disease
• Smokers,tobacco users

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Geetanjali Sharma, BDS

  Post graduate institute of dental sciences,Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nishi Tanwar, MDS

CONTACT

8368126310; nsh_tanwar@yahoo.co.in

Study Design

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

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 12, 2022
• Study Start: November 5, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

IN (1)