Gingival RecessionNCT06366022
Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft
A study testing The tunnel technique for root coverage with CTG with inner side of the graft and The tunnel technique for root coverage with CTG with outer side of the graft in people with Gingival Recession, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- The tunnel technique for root coverage with CTG with inner side of the graft and The tunnel technique for root coverage with CTG with outer side of the graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePoland
- Study dates
- 30 May 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years
- Bilateral multiple gingival recessions in homologous teeth in the same arch.
Who cannot join
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
- Previous periodontal surgery in the area
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, MAzowsze, 00-246
About this study
Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft.
Read the detailed description
Condition or disease:Multiple Gingival Recession
Intervention/treatment:
Device: Modified coronally advanced tunnel with connective tissue graft placed with inner side towards the flap Device: Modified coronally advanced tunnel with subepithelial connective tissue graft with the outer side towards the flap Phase :Not Applicable
- Conditions
- Gingival Recession
- Being tested
- The tunnel technique for root coverage with CTG with inner side of the graft, The tunnel technique for root coverage with CTG with outer side of the graft
- Keywords
- tunneling technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The tunnel technique for root coverage with CTG with inner side of the graftProcedure or surgery
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation). The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
The tunnel technique for root coverage with CTG with outer side of the graftProcedure or surgery
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap. The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
| Study group | Role | What they receive |
|---|---|---|
| The tunnel technique for root coverage with CTG with outer side of the graft | Active comparator | Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
21 participants were enrolled into the study, as it was designed to be a split mouth study Receives: Procedure: The tunnel technique for root coverage with CTG with outer side of the graft |
| The tunnel technique for root coverage with CTG with inner side of the graft | Experimental | Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
21 participants were enrolled into the study, as it was designed to be a split mouth study. Receives: Procedure: The tunnel technique for root coverage with CTG with inner side of the graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Gingival Recession (Mean Root Coverage, MRC)
Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.
- GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side
- GR0- before surgery
- GR6- 6 months after surgery
Measured: Baseline and 6 months after surgery
Secondary outcomes (1)
GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
The analyzed metrics were calculated as follows:
GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome
- GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side
- GT- gingival thickness
- KTW- distance between the gingival margin and the muco-gingival junction (MGJ)
- 0- before surgery
- 6- 6 months after surgery
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start30 May 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartłomiej Górski, PhD, Principal investigator, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366022
- Sponsor's protocol ID
- Warsaw.06
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2024
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft
- ClinicalTrials.gov ID
- NCT06366022
- Acronym / sponsor ID
- Warsaw.06
- Conditions
- Gingival Recession
- Keywords
- tunneling technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft.
Detailed description
Condition or disease:Multiple Gingival Recession
Intervention/treatment:
Device: Modified coronally advanced tunnel with connective tissue graft placed with inner side towards the flap Device: Modified coronally advanced tunnel with subepithelial connective tissue graft with the outer side towards the flap Phase :Not Applicable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The tunnel technique for root coverage with CTG with outer side of the graft | Active comparator | Procedure: The tunnel technique for root coverage with CTG with outer side of the graftProcedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
| The tunnel technique for root coverage with CTG with inner side of the graft | Experimental | Procedure: The tunnel technique for root coverage with CTG with inner side of the graftProcedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Bilateral multiple gingival recessions in homologous teeth in the same arch.
Key exclusion criteria (7 listed)
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
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 |
|---|---|---|
| The tunnel technique for root coverage with CTG with inner side of the graftTunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation). The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft. | Procedure or surgery | The tunnel technique for root coverage with CTG with inner side of the graft |
| The tunnel technique for root coverage with CTG with outer side of the graftTunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap. The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft. | Procedure or surgery | The tunnel technique for root coverage with CTG with outer side of the graft |
Primary outcome
Percent Change in Gingival Recession (Mean Root Coverage, MRC)
Time frame: Baseline and 6 months after surgery
Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%. * GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side * GR0- before surgery * GR6- 6 months after surgery
1 secondary outcome
GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
Time frame: 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bartłomiej Górski, PhD principal investigator
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The tunnel technique for root coverage with CTG with inner side of the graft and The tunnel technique for root coverage with CTG with outer side of the graft in people with Gingival Recession, run by Medical University of Warsaw at 1 site in Poland.
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 2 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 14 May 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 Poland. 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?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Gingival Recession (Mean Root Coverage, MRC) (time frame: Baseline and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.