Gingival RecessionNCT02642887
A Modified Tunnel Approach in Treatment of Gingival Recession
A study testing mTA + SCTG in people with Gingival Recession, run by Al-Azhar University.
Trial summary
Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG). Read more about this study
- Who is it for?
- Ages 29 to 47 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- mTA + SCTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2016
- 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 29 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- except for chronic periodontitis, our patients were systemically free
- Two mandibular Miller Class I or II recession sites
- at least 2 mm attached gingiva.
- at least 3 mm depth of recession.
Who cannot join
- Systemic diseases.
- Smokers or formal smokers
- Pregnant or lactating females
- History of antibiotic therapy at the last 6 months
- Patients who are not willing to follow the study protocol
About this study
Official title: Evaluation of Root Coverage Outcome Using a Modified Tunnel Approach Versus Tunnel Technique: A Randomized Clinical Trial
Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).
Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG and cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months postoperatively. The primary outcome was root coverage esthetic scores (RES).
Read the detailed description
Various techniques have been suggested for the treatment of isolated mandibular recessions e.g., envelope, coronally advanced flaps double pedicle flap or tunneling procedures combined with laterally positioned pedicle flaps in conjunction with SCTG. Despite the fact that the mentioned techniques appear to improve root coverage, the success in terms of complete root coverage has high variability and thus it is still unknown which approach may lead to the most predictable outcomes. The limited evidence from the literature points clearly to the clinical importance of developing new concepts for predictable of isolated mandibular recessions.
The MTA is a dual flap approach; that starts with full thickness flap (avoiding papilla incision) till the level of the mucogingival junction. On reaching the level of the vestibular mucosa, a partial thickness flap is applied to undermine the base of the flap. Using this dual approach carries two main advantages: avoidance of severing the gingival blood supply through the full thickness flap, in addition to minimizing the tension on the flap tissue through using the partial thickness flap at the above-mentioned site.
In this trial, the mTA has been proposed for the surgical treatment of isolated mandibular recessions due to the following advantages: 1) it avoids vertical releasing incisions. 2) it doesn't incise the papilla, which may improve the vascularization of the area plus stabilizing the soft tissue flap. 3) it is suitable to patients with thin gingival biotype.
- Conditions
- Gingival Recession
- Being tested
- mTA + SCTG
- Keywords
- gingival recession, tunnel technique, Miller Class I and II
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTA + SCTGProcedure or surgery
Also called Dual approach + SCTG
These recession defects will be covered by modified tunnel approach; using a full thickness flap till the level of mucogingival junction then, partial thickness flap will be applied in the vestibular mucosa. SCTG will be harvested from the palate, put on the root surface then covered by the mTA and sutured.
| Study group | Role | What they receive |
|---|---|---|
| The test group | Experimental | This group included 30 recession defects treated with mTA + SCTG Receives: Procedure: mTA + SCTG |
| The control group | No intervention | This group included 30 recession defects treated with cTT + SCTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Root Coverage Esthetic Score
This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. It is calculated by expert operator.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (2)
The change in percentage of root coverage
The percentage of root coverage will be calculated at 3 months, then 6 months.
Measured: Baseline, 3 months and 6 months
The change in depth of gingival recession
The change in depth of gingival recession will be calculated at baseline, 3 months and 6 months.
Measured: Baseline, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Helmi Hazzaa, Al-Azhar University
- Investigators
- Hala H Hazzaa, Professor, Principal investigator, Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642887
- Sponsor's protocol ID
- Al-Azhar 11-2014
- Status last verified
- Dec 2015
- First submitted
- 18 Dec 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
PubMed 24641000Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.
PubMed 22639845
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Root Coverage Outcome Using a Modified Tunnel Approach Versus Tunnel Technique: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02642887
- Acronym / sponsor ID
- Al-Azhar 11-2014
- Conditions
- Gingival Recession
- Keywords
- gingival recession, tunnel technique, Miller Class I and II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 30 Dec 2015 (estimated)
- 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.
Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).
Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG and cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months postoperatively. The primary outcome was root coverage esthetic scores (RES).
Detailed description
Various techniques have been suggested for the treatment of isolated mandibular recessions e.g., envelope, coronally advanced flaps double pedicle flap or tunneling procedures combined with laterally positioned pedicle flaps in conjunction with SCTG. Despite the fact that the mentioned techniques appear to improve root coverage, the success in terms of complete root coverage has high variability and thus it is still unknown which approach may lead to the most predictable outcomes. The limited evidence from the literature points clearly to the clinical importance of developing new concepts for predictable of isolated mandibular recessions.
The MTA is a dual flap approach; that starts with full thickness flap (avoiding papilla incision) till the level of the mucogingival junction. On reaching the level of the vestibular mucosa, a partial thickness flap is applied to undermine the base of the flap. Using this dual approach carries two main advantages: avoidance of severing the gingival blood supply through the full thickness flap, in addition to minimizing the tension on the flap tissue through using the partial thickness flap at the above-mentioned site.
In this trial, the mTA has been proposed for the surgical treatment of isolated mandibular recessions due to the following advantages: 1) it avoids vertical releasing incisions. 2) it doesn't incise the papilla, which may improve the vascularization of the area plus stabilizing the soft tissue flap. 3) it is suitable to patients with thin gingival biotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The test group | Experimental | Procedure: mTA + SCTGThis group included 30 recession defects treated with mTA + SCTG |
| The control group | No intervention | –This group included 30 recession defects treated with cTT + SCTG |
Who may qualify
- Ages
- 29 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- except for chronic periodontitis, our patients were systemically free
- Two mandibular Miller Class I or II recession sites
- at least 2 mm attached gingiva.
- at least 3 mm depth of recession.
Key exclusion criteria (5 listed)
- Systemic diseases.
- Smokers or formal smokers
- Pregnant or lactating females
- History of antibiotic therapy at the last 6 months
- Patients who are not willing to follow the study protocol
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 |
|---|---|---|
| mTA + SCTGAlso: Dual approach + SCTGThese recession defects will be covered by modified tunnel approach; using a full thickness flap till the level of mucogingival junction then, partial thickness flap will be applied in the vestibular mucosa. SCTG will be harvested from the palate, put on the root surface then covered by the mTA and sutured. | Procedure or surgery | The test group |
Primary outcome
The change in Root Coverage Esthetic Score
Time frame: Baseline, 3 months and 6 months
This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. It is calculated by expert operator.
2 secondary outcomes
The change in percentage of root coverage
Time frame: Baseline, 3 months and 6 months
The change in depth of gingival recession
Time frame: Baseline, 3 months and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Background: PubMed 24641000Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
- Background: PubMed 22639845Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.
Related trials for Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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.
Hala H Hazzaa, Professor principal investigator
Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
Questions about this trial
What is this clinical trial studying?
A study testing mTA + SCTG in people with Gingival Recession, run by Al-Azhar University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The change in Root Coverage Esthetic Score (time frame: Baseline, 3 months and 6 months). 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 NCT02642887, which also lists 2 linked publications.
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 30 Dec 2015.