Skip to main content
OpenTrials
Completed

NCT Number: NCT07616960

Combined Bilaminar Tunnel Technique in Treating Difficult Gingival Recessions

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Recession, Mucogingival Surgery Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Root Coverage Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. mean root coverage and complete root coverage rate

    Time frame: From enrollment to six month after receiving the treatment

    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.

Secondary outcomes

  1. Correlation Between Clinical and Anatomical Factors and Baseline Recession Depth

    Time frame: perioperative

    The correlation between clinical and anatomical factors and baseline recession depth will be assessed. Clinical and anatomical factors will include baseline keratinized tissue width, tooth angulation, depth of alveolar bone concavity, angulation of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness. Baseline keratinized tissue width and recession depth will be measured clinically in millimeters using a periodontal probe. Tooth angulation and angulation of alveolar bone concavity will be measured in degrees on CBCT images. Depth of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness will be measured in millimeters on CBCT images. The correlation will be evaluated using linear regression analysis.

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

    Time frame: From baseline to 6 month after treatment.

    The correlation between clinical and anatomical factors and mean root coverage after treatment will be assessed. Clinical and anatomical factors will include baseline keratinized tissue width, tooth angulation, depth of alveolar bone concavity, angulation of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness. Baseline keratinized tissue width will be measured clinically in millimeters using a periodontal probe. Tooth angulation and angulation of alveolar bone concavity will be measured in degrees on CBCT images. Depth of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness will be measured in millimeters on CBCT images. Mean root coverage will be calculated as the percentage reduction in recession depth from baseline to 6 months after treatment. The correlation will be evaluated using linear regression analysis.

  3. Association Between Clinical and Anatomical Factors and Complete Root Coverage After Treatment

    Time frame: From baseline to 6 month after treatment

    The association between clinical and anatomical factors and complete root coverage after treatment will be assessed. Clinical and anatomical factors will include baseline keratinized tissue width, tooth angulation, depth of alveolar bone concavity, angulation of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness. Baseline keratinized tissue width will be measured clinically in millimeters using a periodontal probe. Tooth angulation and angulation of alveolar bone concavity will be measured in degrees on CBCT images. Depth of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness will be measured in millimeters on CBCT images. Complete root coverage will be recorded as a binary outcome, defined as the presence or absence of complete coverage of the previously exposed root surface at 6 months after treatment. The association will be evaluated using logistic regression analysis.

Sponsors and collaborators

Lead sponsor

Choying Lin

Other

Registry information

Official study title

Effectiveness of the Combined Bilaminar Tunnel Technique in Treating Anatomically Difficult Gingival Recessions: A Prospective Cohort Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.