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

NCT ID: NCT05953896

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-10-15

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.

Conditions

Gingival Papillary Cratering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hyaluronic acid gel

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

Group Type: EXPERIMENTAL

Hyaluronic acid gel

Intervention Type: 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.

Multilayer L-PRF

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

Group Type: ACTIVE_COMPARATOR

Multilayer L-PRF membranes

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

HA gel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aya Elleithy

OTHER

Sponsor Role: lead

Responsible Party

Aya Elleithy

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aya Alleithy, teaching assistant

Role: PRINCIPAL_INVESTIGATOR

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

Hala Abu El-Ela, proffessor

Role: STUDY_DIRECTOR

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

Susan Sarhan, lecturer

Role: STUDY_DIRECTOR

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

Locations

faculty of Dentistry. Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-REC 012112

Identifier Type: -

Identifier Source: org_study_id