A Modern, Non-surgical Method for Treating Papillary Deficiencies is the Use of Hyaluronic Acid, Which Have Demonstrated Encouraging Outcome. Subperiosteal Hyaluronic Acid Injection Overlay Technique with the Idea of Merging Hyaluronic Acid Injection with Surgical Intervention to Reconstruct Idp

NCT06889311 | Not Yet Recruiting

• 1 other identifier: CEBD-CU-2024-12-16
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The interdental papilla is a crucial part of an esthetic smile, its loss results in gingival black triangles giving unpleasant appearance which directly affect patient self-esteem (Lee et al. 2016). The presence of interdental papilla is of great concern for the clinician and the patient. Gingival black triangles are considered to be the most disliked esthetic issue. As well open embrasures can cause food impaction and phonetic problems (Prato et al. 2004). The treatment of black triangles is challenging in modern dentistry. The treatment options are surgical and non-surgical. Surgical treatments are invasive and do not always give a predictable result due to limited blood supply of the papilla (Mansouri 2013). However, no technique has been set up as a gold standard treatment for gingival black triangles, although, connective tissue graft surgical techniques are the most common used approaches for treatment of black triangles (RahimiRad 2018). A modern, non-surgical method for treating papillary deficiencies is the use of hyaluronic acid, which have demonstrated encouraging outcome (Ni et al. 2021). Subperiosteal hyaluronic acid injection overlay technique was proposed by Spano et al, (2020) with the idea of merging hyaluronic acid injection with simple surgical intervention to reconstruct the lost interdental papilla. As far as we know, there is no present studies comparing hyaluronic acid overlay technique with connective tissue graft in treatment of interdental papilla deficiencies.

Conditions

Interdental Papillae Reconstruction; Hyaluronic Acid

Keywords

Hyaluronic acid, Interdental papilla, Black triangle

Outcome Measures

Primary Outcomes (1)

• Changes in papilla height

  Clinical changes in papilla will be recorded by measuring papilla height at the distance between the tip of the papilla and the incisal edge of the adjacent tooth using UNC periodontal probe .

  Changes will be recorded at 3, 6 and 12 months

Secondary Outcomes (7)

• Percentage of changes in papilla height

  3, 6 and 12 months

• Papilla presence index

  3, 6 and 12 months

• Clinical attachment loss

  3, 6 and 12 months

• Gingival thickness

  3, 6 and 12 months

• Post-operative pain

  1,3 and 10 days post-surgical.

Study Arms (2)

Group A

EXPERIMENTAL

Procedure: Subperiosteal hyaluronic acid injection overlay technique

Group B

ACTIVE COMPARATOR

Procedure: Tunneling with connective tissue graft.

Interventions

Subperiosteal hyaluronic acid injection overlay technique PROCEDURE

using subperiosteal hyaluronic acid injection overlay technique showed promising results in treating lost interdental papilla which needs further assessment to its clinical effectiveness

Group A

Tunneling with connective tissue graft. PROCEDURE

Connective tissue graft base techniques have been for years the most predictable approach for treatment of interdental papillary defects. CTG can as a biological filler which enhances flap stability and wound strength. CTG also can promote coagulation cascade and protects the maturating fibrin clot (Tavelli et al. 2019). Moreover, CTG results in significant increase in gingival tissue thickness which positively improve tissue fill and soft tissue volume creeping which influence esthetic outcomes following periodontal regeneration

Group B

Eligibility Criteria

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

You may qualify if:

• \- 1. Patients aged over 18 years. 2. Class I papillary recession according to the Nordland and Tarnow classification system. (Nordland and Tarnow 1998) 3. Patients free from any systemic conditions that may affect healing. (Hamadeh et al. 2024).
• \. The distance between the contact point to alveolar crest between 5 to 7 mm. 5. Presence of the adjacent teeth. 6. Compliant patients with good oral hygiene.

You may not qualify if:

• \- 1. Smokers. 2. Pregnant females. 3. Patients with active periodontal disease. 4. Patients who has spacing or crowding between the teeth to be treated. 5. Abnormal tooth shape or adjacent teeth with caries. 6. Presence of proximal restoration or orthodontic appliances or fixed prosthesis.
• \. Patients with poor oral hygiene according to plaque index score of 2.0 to 3.0 evaluated according to the criteria of Silness and Loe.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Mostafa A Ghoneim, Master's degree

CONTACT

+201115701116; mostafa.amgad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral Medicine and Periodontology Faculty of Dentistry, Cairo University.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-02