PRF and Connective Tissue Graft in Interdental Papilla Reconstruction

NCT03899051 | Unknown DMC

• 1 other identifier: perio isha
• 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. Perusal of available literature reveals only case reports and case series in the reconstruction of interdental papilla using subepithelial connective tissue graft and platelet rich fibrin autologous graft. Therefore, the current randomized controlled clinical study is intended to compare the effect of platelet rich fibrin and subepithelial connective tissue graft on interdental papilla reconstruction.

Conditions

Reconstructive Surgery

Keywords

interdental papilla reconstruction

Outcome Measures

Primary Outcomes (1)

• Gain in papillary height

  Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.

  6 months

Study Arms (2)

Test group

EXPERIMENTAL

Papilla reconstruction would be done with platelet rich fibrin

Procedure: interdental papilla reconstructive surgery with subepithelial connective tissue graft

Control group

ACTIVE COMPARATOR

Papilla reconstruction would be done with subepithelial connective tissue graft

Procedure: interdental papilla reconstructive surgery with PRF

Interventions

interdental papilla reconstructive surgery with PRF PROCEDURE

Papilla reconstruction would be done with platelet rich fibrin

Control group

interdental papilla reconstructive surgery with subepithelial connective tissue graft PROCEDURE

Papilla reconstruction would be done with subepithelial connective tissue graft

Test group

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 I and class II papillary recession according to Nordland and Tarnow's classification.
• Patients who have completed etiological periodontal therapy (full mouth scaling and root planing) with Plaque index (Silness \& Loe) \<1, gingival index (Loe \& Silness) \<1 and showing adequate compliance and willing to participate in the study.

You may not qualify if:

• Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or 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)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Nishi Tanwar, MDS

  PGIDS,ROHTAK

  STUDY CHAIR

Central Study Contacts

Nishi Tanwar, MDS

CONTACT

8368126310; nsh_tanwar@yahoo.co.in

Study Design

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

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 2, 2019
• Study Start: December 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

IN (1)