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PRF and Connective Tissue Graft in Interdental Papilla Reconstruction

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ClinicalTrials.gov Identifier: NCT03899051
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

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.

Condition or disease Intervention/treatment Phase
Reconstructive Surgery Procedure: interdental papilla reconstructive surgery with PRF Procedure: interdental papilla reconstructive surgery with subepithelial connective tissue graft Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Clinical Evaluation of Platelet Rich Fibrin and Subepithelial Connective Tissue Graft in Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group
Papilla reconstruction would be done with platelet rich fibrin
Procedure: interdental papilla reconstructive surgery with subepithelial connective tissue graft
Papilla reconstruction would be done with subepithelial connective tissue graft

Active Comparator: Control group
Papilla reconstruction would be done with subepithelial connective tissue graft
Procedure: interdental papilla reconstructive surgery with PRF
Papilla reconstruction would be done with platelet rich fibrin




Primary Outcome Measures :
  1. Gain in papillary height [ Time Frame: 6 months ]
    Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899051


Contacts
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Contact: Nishi Tanwar, MDS 8368126310 nsh_tanwar@yahoo.co.in

Locations
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India
Post Graduate Institute of Dental Sciences Recruiting
Rohtak, Haryana, India, 124001
Contact: NISHI TANWAR, MDS    8368126310    nsh_tanwar@yahoo.co.in   
Sponsors and Collaborators
Postgraduate Institute of Dental Sciences Rohtak
Investigators
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Study Chair: Nishi Tanwar, MDS PGIDS,ROHTAK

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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03899051     History of Changes
Other Study ID Numbers: perio isha
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Postgraduate Institute of Dental Sciences Rohtak:
interdental papilla reconstruction