Combined Bilaminar Tunnel Technique in Treating Difficult Gingival Recessions

NCT07616960 | Completed DMC

• 1 other identifier: 202200265A3D001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the combined bilaminar tunnel technique works to treat anatomically difficult gingival recessions. It will also explore whether anatomical factors are associated with root coverage outcomes. The main questions it aims to answer are: Does the combined bilaminar tunnel technique improve root coverage outcomes in patients with anatomically difficult gingival recessions? Are specific anatomical factors associated with root coverage outcomes after the combined bilaminar tunnel technique? Participants will: Receive root coverage surgery using the combined bilaminar tunnel technique Visit the clinic for follow-up evaluations after surgery Receive clinical measurements to assess gingival recession and root coverage outcomes Receive radiographic evaluation to assess anatomical characteristics, if clinically indicated or available

Conditions

Gingival Recession, Mucogingival Surgery; Gingival Recession; Root Coverage

Keywords

root coverage; combined bilaminar tunnel technique; mucogingival surgery

Outcome Measures

Primary Outcomes (1)

• mean root coverage and complete root coverage rate

  Mean root coverage will be calculated as the percentage reduction in gingival recession depth from baseline to the 6 month after receiving the treatment. Gingival recession depth will be measured as the distance from the cemento-enamel junction to the gingival margin.

  From enrollment to six month after receiving the treatment

Secondary Outcomes (3)

• Correlation Between Clinical and Anatomical Factors and Baseline Recession Depth

  perioperative

• Correlation Between Clinical and Anatomical Factors and Mean Root Coverage After Treatment with the Combined Bilaminar Tunnel Technique

  From baseline to 6 month after treatment.

• Association Between Clinical and Anatomical Factors and Complete Root Coverage After Treatment

  From baseline to 6 month after treatment

Study Arms (1)

Patients who received root coverage surgery with combined bilaminar tunnel technique

EXPERIMENTAL

Procedure: mucogingival surgery

Interventions

mucogingival surgery PROCEDURE

Participants will receive root coverage surgery using the combined bilaminar tunnel technique for the treatment of gingival recession. The procedure initiates with a partial-thickness flap at the sites with the most severe recession with tunnelled coronally advanced flap(tCAF), extending from the coronal margin to the mucogingival junction (MGJ). For adjacent teeth, intrasulcular incisions are made to prepare a full-thickness flap using a tunnel knife. A de-epithelialized connective tissue graft is harvested and stabilized at the coronal portion of the recipient site to facilitate root coverage. Simultaneously, a volume-stable collagen matrix (VSCM) is placed apically within the partial-thickness flap to fill bone concavities and reduce tissue retraction forces during healing.

Patients who received root coverage surgery with combined bilaminar tunnel technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Orthodontic patients who were going to be treated with cTUN approach for soft tissue modification.
• Healthy periodontal condition or well controlled periodontitis with periodontal probing depth ≦ 3mm, and absence of bleeding on probing.
• Thin gingival phenotype, determined with visible metal shade\[27\]
• Intact clinical and pre-surgery radiographic data (CBCT) was available, and the patient followed the recommended supportive post-surgery treatment at least 6 month after the surgery.
• Informed consent had been obtained prior to the mucogingival surgery.

You may not qualify if:

• Uncontrolled systemic disease, such as hypertension, diabetes.
• Untreated periodontitis
• History of radiation therapy on head and neck regions.
• Heavy smokers (more than 0.5 pack per day).
• Patient with pregnancy or breastfeeding.
• History of mucogingival surgery performed on the same site.
• Patient who did not comply to the recommended supportive treatment was regarded as erratic complier.

Sponsors & Collaborators

• Choying Lin: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Location

Related Publications (1)

• Lin CY, Chiu MY, Kuo PY, Chen Z, Wang HL. A Combined Bilaminar Tunnel Technique Using a Volume-Stable Collagen Matrix for Root Coverage in Anatomically Complex Sites: Technique Description and Report of Two Cases. Int J Periodontics Restorative Dent. 2025 Oct 6;0(0):1-26. doi: 10.11607/prd.7886. Online ahead of print.

  PMID: 41052290 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and associate professor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 1, 2026
• Study Start: April 27, 2022
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

TW (1)