Gingival RecessionNCT04133298
Evaluation of SECTG Vs. Laser-DGG in Management of Gingival Recessions.
A study testing Tunneling with laser de-epithelized gingival graft and Tunnelingwith subepithelial connective tissue graf in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates laser de-epithelialized gingival graft to be as effective as subepithelial connective tissue graft in management of multiple gingival recessions using tunneling technique. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunneling with laser de-epithelized gingival graft and Tunnelingwith subepithelial connective tissue graf
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Jun 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anterior teeth and premolars with multiple Miller's Class I and II gingival recessions.
- Identifiable cemento-enamel junction.
- The teeth with gingival recessions are vital teeth.
- Plaque Index and Gingival bleeding index less than 20% after phase one therapy.
Who cannot join
- Patients with systemic diseases and medical conditions that may affect the treatment outcomes.
- Prosthetic crown, restoration or tooth decay involving the CEJ.
- Previous periodontal surgery in the area of interest.
- Smokers.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tunneling Technique With Subepithelial Connective Tissue Graft Vs. Laser De-epithelialized Gingival Graft in Management of Multiple Cairo RT-2 Gingival Recessions.
This study evaluates laser de-epithelialized gingival graft to be as effective as subepithelial connective tissue graft in management of multiple gingival recessions using tunneling technique. half pf participants will be treated from gingival recession using tunneling technique with laser de-epithelized gingival graft, while the other half will be treated using tunneling technique with subepithelial connective tissue graft.
Read the detailed description
Tunneling technique is a minimal invasive method for coronal advancement during gingival recession coverage. The technique provide better blood supply which enhances wound healing and results in successful root coverage and attachment gain. Tunneling technique is suggested to be incorporated with a soft tissue tissue for better recipient site outcome.
In a systemic review and meta-analysis conducted in 2019 there was limited evidence available comparing subepithelial connective tissue graft to the de-epithelialized gingival graft. However the de-epithelialized gingival graft showed superior mean root coverage, keratinized tissue gain and clinical attachment gain over the subepithelial connective tissue graft making it the technique of choice when incorporated with coronal advancement flap in treatment of gingival recession. Laser de-epithelization may enrich the advantages of the conventional de-epithelization method where more uniform predictable epithelization can be obtained.
- Conditions
- Gingival Recession
- Being tested
- Tunneling with laser de-epithelized gingival graft, Tunnelingwith subepithelial connective tissue graf
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneling with laser de-epithelized gingival graftProcedure or surgery
After the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing .
Tunnelingwith subepithelial connective tissue grafProcedure or surgery
After administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid
| Study group | Role | What they receive |
|---|---|---|
| Tunneling with laser de-epithelized gingival graft. | Active comparator | After the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing . Receives: Procedure: Tunneling with laser de-epithelized gingival graft |
| Tunnelingwith subepithelial connective tissue graft. | Active comparator | After administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid. Receives: Procedure: Tunnelingwith subepithelial connective tissue graf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Thickness gain
it will be calculated based on volumetric difference of a defined area located on attached gingiva above the site to be corrected surgically, that is by taking a base line digital impression and superimpose it to another digital impression 6 month postoperatively. Buccal tooth surface will be used as a reference for the superimposition procedure. The digital measurements will be taken to nearest 0.01mm. Finally, gingival thickness gain will be calculated as the measured volume gain per measured area, [Gingival thickness gain (mm) = volume (mm3) / area (mm2)].
Measured: 6 month
Secondary outcomes (6)
root coverage gain
it will be calculated digitally by comparing base line digital impression to a 6 month postsurgical digital impression. A digital ruler will be used to measure the distance from gingival margin to the cemento-enamel junction on a point mid-buccally pre-surgically then post-surgically. The digital measurements will be taken to nearest 0.01mm.
Mean of root coverage and its percentage will be calculated. Mean root coverage will be measured in millimeters and percentage in percent.
Measured: 6 month
Keratinized tissue width gain
Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.
Measured: 6 month
Probing depth
Will be measured by a periodontal probe from the base of sulcus/pocket to the gingival margin mid- buccally.
Measured: 6 month
Clinical attachment level gain
Will be measured by a periodontal probe from the base of sulcus/pocket to the cement enamel junction mid- buccally.
Measured: 6 month
Post-operative pain score
Patients will be questioned in arabic after two weeks post-operative to assess pain, number of analgesic pills taken and number of days pills were taken. That will be assessed by visual analog scale (VAS) graduated from one to ten, where one indicates minimal pain and ten refers to severe pain.
Measured: 2 weeks
Patient satisfaction
Patients will be questioned in arabic about the palatal wound after two weeks of the surgery. The questionnaire will include four graduated visual analog scales to describe pain intensity, hemorrhage intensity, fear of jeopardizing the palatal wound, their chewing ability, their willingness to perform the surgery another time if needed and their satisfaction about the esthetic outcome after the surgery. Graduation will be from one to ten, where one indicates minimal and ten refers to severe.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Mar 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal, Cairo University
- Investigators
- Mohamed Akawi, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133298
- Sponsor's protocol ID
- 25354999
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tunneling Technique With Subepithelial Connective Tissue Graft Vs. Laser De-epithelialized Gingival Graft in Management of Multiple Cairo RT-2 Gingival Recessions.
- ClinicalTrials.gov ID
- NCT04133298
- Acronym / sponsor ID
- 25354999
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Oct 2019 (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.
This study evaluates laser de-epithelialized gingival graft to be as effective as subepithelial connective tissue graft in management of multiple gingival recessions using tunneling technique. half pf participants will be treated from gingival recession using tunneling technique with laser de-epithelized gingival graft, while the other half will be treated using tunneling technique with subepithelial connective tissue graft.
Detailed description
Tunneling technique is a minimal invasive method for coronal advancement during gingival recession coverage. The technique provide better blood supply which enhances wound healing and results in successful root coverage and attachment gain. Tunneling technique is suggested to be incorporated with a soft tissue tissue for better recipient site outcome.
In a systemic review and meta-analysis conducted in 2019 there was limited evidence available comparing subepithelial connective tissue graft to the de-epithelialized gingival graft. However the de-epithelialized gingival graft showed superior mean root coverage, keratinized tissue gain and clinical attachment gain over the subepithelial connective tissue graft making it the technique of choice when incorporated with coronal advancement flap in treatment of gingival recession. Laser de-epithelization may enrich the advantages of the conventional de-epithelization method where more uniform predictable epithelization can be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tunneling with laser de-epithelized gingival graft. | Active comparator | Procedure: Tunneling with laser de-epithelized gingival graftAfter the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing . |
| Tunnelingwith subepithelial connective tissue graft. | Active comparator | Procedure: Tunnelingwith subepithelial connective tissue grafAfter administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Anterior teeth and premolars with multiple Miller's Class I and II gingival recessions.
- Identifiable cemento-enamel junction.
- The teeth with gingival recessions are vital teeth.
- Plaque Index and Gingival bleeding index less than 20% after phase one therapy.
Key exclusion criteria (5 listed)
- Patients with systemic diseases and medical conditions that may affect the treatment outcomes.
- Prosthetic crown, restoration or tooth decay involving the CEJ.
- Previous periodontal surgery in the area of interest.
- Smokers.
- Pregnancy.
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 |
|---|---|---|
| Tunneling with laser de-epithelized gingival graftAfter the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing . | Procedure or surgery | Tunneling with laser de-epithelized gingival graft. |
| Tunnelingwith subepithelial connective tissue grafAfter administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid | Procedure or surgery | Tunnelingwith subepithelial connective tissue graft. |
Primary outcome
Gingival Thickness gain
Time frame: 6 month
it will be calculated based on volumetric difference of a defined area located on attached gingiva above the site to be corrected surgically, that is by taking a base line digital impression and superimpose it to another digital impression 6 month postoperatively. Buccal tooth surface will be used as a reference for the superimposition procedure. The digital measurements will be taken to nearest 0.01mm. Finally, gingival thickness gain will be calculated as the measured volume gain per measured area, [Gingival thickness gain (mm) = volume (mm3) / area (mm2)].
6 secondary outcomes
root coverage gain
Time frame: 6 month
Keratinized tissue width gain
Time frame: 6 month
Probing depth
Time frame: 6 month
Clinical attachment level gain
Time frame: 6 month
Post-operative pain score
Time frame: 2 weeks
Patient satisfaction
Time frame: 2 weeks
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 3 Aug 2023.
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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.
Mohamed Akawi principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunneling with laser de-epithelized gingival graft and Tunnelingwith subepithelial connective tissue graf in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 3 Aug 2023. 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 Egypt. 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?
Gingival Thickness gain (time frame: 6 month). 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 3 Aug 2023.