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

Efficacy of Hyaluronic Acid Gel Injection Versus Multilayer Leukocyte Platelet Rich Fibrin (L-PRF) in The Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingival Papillary Cratering
• Intervention / Treatment: Combination product: Hyaluronic acid gel; Combination product: Multilayer L-PRF membranes

Detailed Description

A total of 20 patients recruited from the outpatient clinic of Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of Dentistry, Ain-Shams University and seeking treatment for black triangles for esthetic reason. Patients meeting the eligibility criteria are equally and randomly allocated in two different groups. group one Included 10 patients who received interdental papillary reconstruction using multiple layers of L-PRF. Group two Included 10 patients who received interdental papillary reconstruction using Hyaluronic acid gel injection. In the follow-up phase, patients were recalled after 3 and 6 months from intervention where clinical re-measurement of the black triangles and standardized digital clinical photographs and radiographs are done. Black triangle height and surface area was measured and other clinical parameters (Modified papillary bleeding index, Gingival index, clinical attachment level and periodontal probing depth) were assessed at baseline, 3 months and 6 months periods. patient satisfaction was evaluated using the patient satisfaction questionnaire (PSQ-18, short form) at baseline. pain and discomfort was evaluated using Numerical rating scale (NRS) at baseline, 3 months and 6 months periods. Global esthetic improvement scale (GAIS) was evaluated at 3 months and 6 months periods.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • faculty of Dentistry. Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Both genders aged from 18-45 years.
2. Systemically healthy patients.
3. 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)
4. 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.
5. A band of keratinized tissue should be present around the test teeth ≥ 2 mm
6. 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
7. 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.

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid gel; will include 10 patients undergoing non invasive reconstruction of interdental papilla using injectable Hyaluronic acid gel	Combination product: Hyaluronic acid gel; 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.; Other Names: HA gel
Active Comparator: Multilayer L-PRF; will include 10 patients undergoing minimally invasive surgery for reconstruction of interdental papilla using multilayer L-PRF membranes	Combination product: Multilayer L-PRF membranes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment pf patient satisfaction using Patient Satisfaction Questionnaire	evaluation of patient satisfaction using patient Satisfaction questionnaire (PSQ-18, short form), patients are informed to fill and sign the questionnaire with 18 questions to evaluate their satisfaction of the recieved intervention	patients scores are evaluated at baseline immediately after the procedure
Post operative pain assessment using Numerical Pain Rating Scale	To evaluate patient's perception of postoperative pain during the treatment time using the NRS (Numeric Pain Rating Scale). The NRS is an 11-point numeric scale that ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")	six months
Assessment of esthetic appearance using the GAIS (global esthetic improvement scale)	patients satisfaction of their esthetic appearance will be rocorded using the global esthetic improvement scale with ranges (1: worsened) (2: unchanged) (3: improved) (4: much improved)	six months

Collaborators and Investigators

• Sponsor: Aya Elleithy
• Investigators: Principal Investigator: Aya Alleithy, teaching assistant, Teaching assistant at Department of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, A; Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hyaluronic acid gel; interdental papilla; multilayer L-PRF
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: FDASU-REC 012112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No