Gingival Recession, Mucogingival SurgeryNCT07616960
Combined Bilaminar Tunnel Technique in Treating Difficult Gingival Recessions
A study testing mucogingival surgery in people with Gingival Recession, Mucogingival Surgery and Gingival Recession, run by Choying Lin at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gingival Recession, Mucogingival Surgery, Gingival Recession, Root Coverage
- What is being tested?
- mucogingival surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Apr 2022to 26 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Combined Bilaminar Tunnel Technique in Treating Anatomically Difficult Gingival Recessions: A Prospective Cohort Study
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?
Read more
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
- Being tested
- mucogingival surgery
- Keywords
- root coverage, combined bilaminar tunnel technique, mucogingival surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mucogingival surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received root coverage surgery with combined bilaminar tunnel technique | Experimental | Not described Receives: Procedure: mucogingival surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to six month after receiving the treatment
Secondary outcomes (3)
Correlation Between Clinical and Anatomical Factors and Baseline Recession Depth
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.
Measured: perioperative
Correlation Between Clinical and Anatomical Factors and Mean Root Coverage After Treatment with the Combined Bilaminar Tunnel Technique
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.
Measured: From baseline to 6 month after treatment.
Association Between Clinical and Anatomical Factors and Complete Root Coverage 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.
Measured: From baseline to 6 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start27 Apr 2022
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, Mucogingival SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Choying Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Choying Lin, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616960
- Sponsor's protocol ID
- 202200265A3D001
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41052290
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Combined Bilaminar Tunnel Technique in Treating Anatomically Difficult Gingival Recessions: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07616960
- Acronym / sponsor ID
- 202200265A3D001
- Keywords
- root coverage, combined bilaminar tunnel technique, mucogingival surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Choying LinUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received root coverage surgery with combined bilaminar tunnel technique | Experimental | Procedure: mucogingival surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mucogingival surgeryParticipants 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. | Procedure or surgery | Patients who received root coverage surgery with combined bilaminar tunnel technique |
Primary outcome
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.
3 secondary outcomes
Correlation Between Clinical and Anatomical Factors and Baseline Recession Depth
Time frame: perioperative
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.
Association Between Clinical and Anatomical Factors and Complete Root Coverage After Treatment
Time frame: From baseline to 6 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 41052290Lin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mucogingival surgery in people with Gingival Recession, Mucogingival Surgery and Gingival Recession, run by Choying Lin at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean root coverage and complete root coverage rate (time frame: From enrollment to six month after receiving the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.