Efficacy of HA Gel Injection Versus Multilayer (L-PRF) in the Interdental Papilla Reconstruction

NCT05953896 | Completed DMC

• 1 other identifier: FDASU-REC 012112
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to investigate the effectiveness of non invasive application Hyaluronic acid gel injection versus minimally invasive surgical approach using multilayer L-PRF both clinically and radiographically as a suitable treatment modality for interdental papillary deficiency.

Conditions

Gingival Papillary Cratering

Keywords

interdental papilla; multilayer L-PRF; Hyaluronic acid gel

Outcome Measures

Primary Outcomes (1)

• The gingival black triangle height

  to evaluate the influence of hyaluronic acid gel injection versus multilayer L-PRF on the height of black triangle

  six months

Secondary Outcomes (3)

• Assessment pf patient satisfaction using Patient Satisfaction Questionnaire

  patients scores are evaluated at baseline immediately after the procedure

• Post operative pain assessment using Numerical Pain Rating Scale

  six months

• Assessment of esthetic appearance using the GAIS (global esthetic improvement scale)

  six months

Study Arms (2)

Hyaluronic acid gel

EXPERIMENTAL

will include 10 patients undergoing non invasive reconstruction of interdental papilla using injectable Hyaluronic acid gel

Combination Product: Hyaluronic acid gel

Multilayer L-PRF

ACTIVE COMPARATOR

will include 10 patients undergoing minimally invasive surgery for reconstruction of interdental papilla using multilayer L-PRF membranes

Combination Product: Multilayer L-PRF membranes

Interventions

Hyaluronic acid gel COMBINATION_PRODUCT

For the Hyaluronic acid gel group: HA gel was injected 2-3mm apical to the coronal tip of the involved papillae and the needle was directed coronally with an angulation of 45° to the long axis of the tooth, and the bevel directed apically until papilla became blanched. The injection was given at each papilla at the following intervals baseline, one week and two weeks.

Also known as: HA gel

Hyaluronic acid gel

Multilayer L-PRF membranes COMBINATION_PRODUCT

For the multilayer L-PRF group: A single semilunar incision is made in the buccal vestibule, apical to the muco-gingival junction in the mid interproximal area of the papilla to be treated.Tunneling of the incisions has maintained the full height and thickness of the gingiva. Multilayer L-PRF membranes were prepared according to Pinto's protocol immediately prior to the surgery and placed in the tunnel then incision was closed with simple interrupted sutures.

Multilayer L-PRF

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders aged from 18-45 years.
• Systemically healthy patients.
• Patients with IDP loss class I or II of esthetic zone in upper and lower anterior and premolar teeth according to Nordland and Tarnow's classification (Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ)
• Presence of sufficient interdental alveolar bone (i.e. the vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 5 mm) that was confirmed clinically by bone sounding.
• A band of keratinized tissue should be present around the test teeth ≥ 2 mm
• Periodontal phenotype of the area to be treated is ≥ 2 mm in thickness. Surgical reconstruction of IDP is influenced by gingival tissue phenotype, outcome of papilla reconstruction is better in cases with a thick gingival unit
• Patients with good oral hygiene and caring about esthetics and concerned to go through the management of "black triangles" by interdental papillae reconstruction in esthetic zone.

You may not qualify if:

• Teeth with acute periapical pathosis.
• Patients with poor oral hygiene, incompliance to treatment and persistence of gingival inflammation after phase I therapy.
• Pregnant and lactating females.
• Patients having para-functional habits or local causes as, malocclusion, interdental spacing, rotation, inclination or crowding.
• Smokers, alcoholics or drug abusers.
• Vulnerable group of patients, orphans, handicapped, prisoners or mentally retarded patients.

Sponsors & Collaborators

• Aya Elleithy: lead

Study Sites (1)

faculty of Dentistry. Ain Shams University

Cairo, Egypt

Location

Study Officials

• Aya Alleithy, teaching assistant

  Teaching assistant at Department of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, A

  PRINCIPAL INVESTIGATOR

• Hala Abu El-Ela, proffessor

  Professor of Oral Medicine, Periodontology and Oral Diagnosis , Faculty of Dentistry-Ain Shams University & Misr International university

  STUDY DIRECTOR

• Susan Sarhan, lecturer

  Lecturer of Oral Medicine and Periodontology and Oral diagnosis, Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: this study is designed as a parallel randomized controlled clinical trial

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: July 20, 2023
• Study Start: January 10, 2022
• Primary Completion: July 10, 2022
• Study Completion: October 15, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)