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Clinical Trials/CTRI/2025/09/094751
CTRI/2025/09/094751
Completed
Phase 4

Comparative Evaluation of Injectable Platelet Rich Fibrin and Placental Extract in the Management of Gingival Black Triangles.

Moturi Padmini Raj1 site in 1 country28 target enrollmentStarted: October 1, 2025Last updated:

Overview

Phase
Phase 4
Status
Completed
Sponsor
Moturi Padmini Raj
Enrollment
28
Locations
1
Primary Endpoint
Interdental papillary height

Overview

Brief Summary

This study is a
randomized, parallel group clinical trial comparing the efficacy of the
placental extract and i-PRF for the management of deficient interdental
papilla. Interdental papillary deficiency creates open gingival embrasures,
also called “black triangles” which
compromises
esthetics, increases the retention of food debris and causes phonetic problems. Various surgical and non-surgical
approaches have been put forth for the management of the black triangles

Placenta is enriched with mesenchymal cells which have the capacity to differentiate into different types of cells. It promotes fibrogenesis, neo angiogenesis and epithelialization thus boosting the wound healing. It also has anti-inflammatory, antimicrobial, immune stimulating, anti-platelet aggregation properties.

Injectable platelet-rich fibrin (i PRF), is a second-generation autologous platelet concentrate. It promotes tissue regeneration, wound healing, improves angiogenesis and has an anti-inflammatory and anti-microbial property.

All the patients will receive phase I therapy which include supragingival and subgingival scaling and root planning. Patients will be recalled after one-week and clinical parameters such as Papillary Bleeding Index and Interdental Papillary Height will be recorded before the procedure. Pre operative photographs will be taken and ImageJ software program will be used to measure BTH, BTW and BTA. After administration of a local anaesthesia 2% lignocaine containing adrenaline 1:80,000. The needle will be inserted at a 45o angle in an area 2 to 3 mm below the interdental papilla tip.

Group A :0.2 mL of a placental extract (Placentrex®) Group B: 0.2 mL of i-PRF. Patient will be recalled after 1 and 3 months for recording clinical parameters. Post-operative photographs will be taken to measure BTH, BTW and BTA.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Individuals with age group of 20-45 years of either gender.
  • Patients with PPI 2 interdental papillary loss with no radiographic evidence of bone loss in maxillary anterior tooth region.
  • Respective teeth are free from caries with no fixed prosthesis or orthodontic appliance.

Exclusion Criteria

  • Patients with systemic disease
  • Pregnant and lactating women.
  • Any forms of tobacco users.
  • Patients consuming drugs causing gingival hyperplasia.
  • Patient who had undergone periodontal plastic surgery for the selected area in the last 1 year.
  • Adjacent teeth with caries, fixed prosthesis, or orthodontic appliance.

Outcomes

Primary Outcomes

Interdental papillary height

Time Frame: baseline,1 and 3 months

Secondary Outcomes

  • •Papillary Bleeding Index (PBI)

Investigators

Sponsor
Moturi Padmini Raj
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Moturi Padmini Raj

Sibar Institute of Dental Sciences

Study Sites (1)

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