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

Not Applicable

Completed

• Conditions: Gingival Papillary Cratering
• Interventions: Combination Product: Hyaluronic acid gel; Combination Product: Multilayer L-PRF membranes

• Registration Number: NCT05953896
• Lead Sponsor: Aya Elleithy

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.

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 Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-07-10
• Study Completion: 2022-10-15
• Study First Submitted: 2023-03-17
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid gel	Hyaluronic acid gel	will include 10 patients undergoing non invasive reconstruction of interdental papilla using injectable Hyaluronic acid gel
Multilayer L-PRF	Multilayer L-PRF membranes	will include 10 patients undergoing minimally invasive surgery for reconstruction of interdental papilla using multilayer L-PRF membranes

Primary Outcome Measures

Name	Time	Method
The gingival black triangle height	six months	to evaluate the influence of hyaluronic acid gel injection versus multilayer L-PRF on the height of black triangle

Secondary Outcome Measures

Name	Time	Method
Assessment pf patient satisfaction using Patient Satisfaction Questionnaire	patients scores are evaluated at baseline immediately after the procedure	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
Assessment of esthetic appearance using the GAIS (global esthetic improvement scale)	six months	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)
Post operative pain assessment using Numerical Pain Rating Scale	six months	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")

Trial Locations

Locations (1)

faculty of Dentistry. Ain Shams University; 🇪🇬 Cairo, Egypt