The Clinical Effects of Using Collagen Matrix in Papilla Augmentation: a Prospective Clinical Trial. Augmenting Fibro-Gide in Interdental Area Using Tunneling Technique to Treat Black Triangles (Papilla Loss)

NCT06853704 | Completed Phase 2 DMC

• 1 other identifier: JUST university IRBID Jordan
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Black triangles, also known as open gingival embrasures, are usually the result of the lack of papilla fill interdentally. With the improvement of dental procedures and materials, more attention has been directed to improving this unesthetic occurrence. Improvement of papilla loss (black triangle) can be mainly categorized into non-surgical and surgical techniques with most surgical modalities focused on a minimally invasive approach due to the restricted working area and blood supply to the papilla. Collagen matrix offers strong mechanical properties while promoting tissue healing and hence is used in many periodontal plastic surgeries (gum surgeries). However, the outcome of collagen matrix in treating papilla loss has not been studied yet. This study aimed to see at the clinical effects of collagen matrix in papilla augmentation using a minimally invasive surgical approach. Patients with papillae loss were selected and Collagen matrix (Geistlich Fibro-Gide) used to stabilize the affected area with a minimally invasive surgical procedure. Papilla height gain, texture and color will be assessed pre-operatively, three and six months postoperatively. in addition, probing depth, clinical attachment level and keratinized tissue width will also be assessed.

Conditions

Dental Papilla Loss, Black Triangles; Black Traingles; Interdental Papillae Reconstruction; Interdental Papilla Augmentation; Interdental Papilla Loss

Keywords

papilla; papilla loss; tunnelling; papilla augmentaion

Outcome Measures

Primary Outcomes (1)

• papilla height

  papilla loss , papilla height reduction , before and after the surgery measuring from contact point to interdental tissue level.

  6 months

Secondary Outcomes (1)

• esthetic score, texture,color,contour

  6 months

Study Arms (1)

study group

EXPERIMENTAL

on group of patients with papilla loss

Procedure: papillary unit advancement

Interventions

papillary unit advancement PROCEDURE

collagen matrix augmentation in papilla area using tunneling technique, up to my knowledge, it's the first time to use collagen matrix in treating papilla, in less invasive approach, only though tunneling with no primary and secondary incisions. so, the technique is designed to be less invasive, maximizing papillary blood supply. and to use xeno collagen matrix instead of connective tissue graft used in previous study. so \~ less morbidity, less postoperative pain with no Donar graft site .

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients above the age of 18 years old with papilla loss.
• papilla loss between 2 natural teeth.
• Absence of active periodontal disease.
• Patients willing to follow oral hygiene measures.
• At least one papillary recession in the maxilla from UR5 to UL5.
• Papillay recession classified as 1 or 2 according to Nordland and Tarnow classification 1998.
• Sites with less than 7 mm measurement from the contact point to the bone crest.
• Sites having adequate width of attached gingiva(\>2mm).

You may not qualify if:

• Patients with incorrect crown or restoration margins, and/or caries.
• Patients undergoing orthodontic treatment.
• Patients who consume alchohol/smoking .
• Papilla loss around dental implant.
• Patients with any systemic disease that may compromise or affect the results of the surgical procedure.
• Breast feeding or pregnant woman.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

King Abdullah University Hospital

Irbid, Jordan

Location

Study Officials

• dr reem sami abdelhafez prof rola alhabashneh, prof

  Jordan University of Science and Technology

  STUDY DIRECTOR

• Bahaaaldin Alsharif

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: it's a clinical trial to see the effects of collagen matrix, using it for the first time in papilla augmentation.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: June 15, 2023
• Primary Completion: July 20, 2024
• Study Completion: September 8, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

JO (1)