Clinical trial NCT05953896: Efficacy of HA Gel Injection Versus Multilayer (L-PRF) in the Interdental Papilla Reconstruction
Official title: Efficacy of Hyaluronic Acid Gel Injection Versus Multilayer Leukocyte Platelet Rich Fibrin (L-PRF) in The Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Papillary Cratering
Keywords: interdental papilla
multilayer L-PRF
Hyaluronic acid gel
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this study is designed as a parallel randomized controlled clinical trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The gingival black triangle height
timeFrame: six months
Secondary outcomes:
measure: Assessment pf patient satisfaction using Patient Satisfaction Questionnaire
timeFrame: patients scores are evaluated at baseline immediately after the procedure
measure: Post operative pain assessment using Numerical Pain Rating Scale
timeFrame: six months
measure: Assessment of esthetic appearance using the GAIS (global esthetic improvement scale)
timeFrame: six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of Dentistry. Ain Shams University
Study officials:
affiliation: Teaching assistant at Department of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, A
name: Aya Alleithy, teaching assistant
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Oral Medicine, Periodontology and Oral Diagnosis , Faculty of Dentistry-Ain Shams University & Misr International university
name: Hala Abu El-Ela, proffessor
role: STUDY_DIRECTOR
affiliation: Lecturer of Oral Medicine and Periodontology and Oral diagnosis, Faculty of Dentistry, Ain Shams University
name: Susan Sarhan, lecturer
role: STUDY_DIRECTOR
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