Clinical Evaluation of Interdental Papilla Reconstruction Using Injectable Autogenous Fat Versus Hyaluronic Acid Filler.

NCT05579522 | Unknown

• 1 other identifier: PER313
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized controlled trial is to evaluate the amount of interdental papilla fill following the injection of the fat graft compared to hyaluronic acid filler in patients with interdental papilla deficiency. Highly motivated patients having at least one deficient papilla with the presence of a contact point between adjacent teeth in the inter-bicuspid region. Papillary deficiency types I or II, according to Nordland and Tarnow (1998)classification will be selected. The main question it aims to answer is: In patient with interdental papillary deficiency, will injecting autogenous fat increase papilla height compared to hyaluronic acid injection? Participants in the test group will receive fat graft injection in the inter dental papilla. In the injection phase, 3 injections will be given at each papilla site: at baseline, 3 and 6 weeks intervals. While in the control group, hyaluronic acid injection in the interdental papilla and also 3 injections will be given at each papilla site at the same intervals.

Conditions

Hyaluronic Acid; Fat Graft

Outcome Measures

Primary Outcomes (1)

• change in Black Triangle Height (BTH)

  • The black triangle height (BTH) will be assessed using standardized digital clinical photographs and analyzed by an image analysis program (Photoshop Cs 5, Adobe Systems, San Jose, CA, USA).

  Specific measurement time point: at baseline and after 6 months postoperatively.

Secondary Outcomes (4)

• change in Black triangle area

  Specific measurement time point: at baseline and after 6 months postoperatively.

• change in Black triangle width

  Specific measurement time point: at baseline and after 6 months postoperatively.

• Post-operative pain

  will be measured at 24 hours.

• Post-Surgical Patient Satisfaction:

  will be measured after 1 week

Study Arms (2)

injectable fat graft

EXPERIMENTAL

Injection of fat graft from the buccal pad of fat into the interdental papilla

Procedure: Fat graft injection

hyaluronic acid filler

ACTIVE COMPARATOR

injection of hyaluronic acid filler in the interdental papilla

Procedure: Hyaluronic acid injection

Interventions

Fat graft injection PROCEDURE

Fat graft injection in the interdental papilla.

injectable fat graft

Hyaluronic acid injection PROCEDURE

Hyaluronic acid injection in the interdental papilla

hyaluronic acid filler

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Highly motivated patients having at least one deficient papilla in the inter-bicuspid region.
• Papillary deficiency types I or II, according to Nordland and Tarnow classification \[13\]
• No radiographic evidence of bone loss interproximally. (Cardaropoli et al,2004)
• Full mouth plaque index (PI) and gingival index (GI) scores should be less than 20%.
• No open contacts between affected teeth should be present.
• Teeth free from caries, proximal restorations, fixed prosthesis or orthodontic appliances

You may not qualify if:

• Subjects with medical conditions that may affect periodontal healing or regeneration.
• Subjects with a history of allergic reactions, smokers, and alcoholics
• Pregnant or breastfeeding females
• Patients with current or previous drugs intake that may predispose to gingival enlargement.
• Patients under orthodontic treatment or had orthodontic treatment in the past six months
• Patients with a history of periodontal surgeries over the last six months at the area of interest

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 13, 2022
• Study Start: October 10, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10