Gingival RecessionNCT03657706
Tunneling Technique in Treatment of Miller's Class III Gingival Recession
A study testing group A (Tunnel procedure with subepithelial connective tissue graft (sCTG) and group B (Tunnel procedure with modified free gingival graft (mFGG)) in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- group A (Tunnel procedure with subepithelial connective tissue graft (sCTG) and group B (Tunnel procedure with modified free gingival graft (mFGG))
- 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
- 15 Jun 2018to Oct 2020
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with healthy systemic condition.
- Buccal recession defects classified as Miller class III.
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20%.
Who cannot join
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery.
- Unmotivated, uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Aesthetic Outcome After Root Coverage Using Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Modified Free Gingival Graft in Miller's Class III Recession Defect: a Randomized Clinical Trial
Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects.
In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.
Read the detailed description
In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position.
Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.
- Conditions
- Gingival Recession
- Being tested
- group A (Tunnel procedure with subepithelial connective tissue graft (sCTG), group B (Tunnel procedure with modified free gingival graft (mFGG))
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)Procedure or surgery
Also called Tunnel procedure with subepithelial connective tissue graft (sCTG), Autogenous sCTG will be used with tunnel procedure
Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
group B (Tunnel procedure with modified free gingival graft (mFGG))Procedure or surgery
Also called Tunnel procedure with modified free gingival graft (mFGG), Autogenous mFGG will be used with tunnel procedure
modified free gingival graft (autogenous graft) will be harvested from the palate and will be used with the prepared tunnel to be used in treating gingival recession
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | tunnel procedure with subepithelial connective tissue graft (sCTG) Receives: Procedure: group A (Tunnel procedure with subepithelial connective tissue graft (sCTG) |
| group B | Active comparator | tunnel procedure with modified free gingival graft (mFGG) Receives: Procedure: group B (Tunnel procedure with modified free gingival graft (mFGG)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
root coverage aesthetic score (RES)
RES evaluated five variables 6 months: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables.
The ideal esthetic score was 10. Zero points were assigned if the final position of the gingival margin was equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ. Zero points were also assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment
Measured: 6 months
Secondary outcomes (1)
recession depth
Measured from the cemento-enamel junction the most apical extension of the gingival margin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionOct 2020 (estimated)
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, Nourhan Abdallah Abdelkhalek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657706
- Sponsor's protocol ID
- CEBD-CU-2018-06-34
- Status last verified
- Sep 2018
- First submitted
- 26 Jun 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all the study records may be shared except that include participant name or personal information identifiers
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Aesthetic Outcome After Root Coverage Using Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Modified Free Gingival Graft in Miller's Class III Recession Defect: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03657706
- Acronym / sponsor ID
- CEBD-CU-2018-06-34
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Sep 2018 (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.
Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects.
In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.
Detailed description
In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position.
Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)tunnel procedure with subepithelial connective tissue graft (sCTG) |
| group B | Active comparator | Procedure: group B (Tunnel procedure with modified free gingival graft (mFGG))tunnel procedure with modified free gingival graft (mFGG) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with healthy systemic condition.
- Buccal recession defects classified as Miller class III.
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20%.
Key exclusion criteria (4 listed)
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery.
- Unmotivated, uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
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 |
|---|---|---|
| group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)Also: Tunnel procedure with subepithelial connective tissue graft (sCTG), Autogenous sCTG will be used with tunnel procedureSubepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession | Procedure or surgery | group A |
| group B (Tunnel procedure with modified free gingival graft (mFGG))Also: Tunnel procedure with modified free gingival graft (mFGG), Autogenous mFGG will be used with tunnel proceduremodified free gingival graft (autogenous graft) will be harvested from the palate and will be used with the prepared tunnel to be used in treating gingival recession | Procedure or surgery | group B |
Primary outcome
root coverage aesthetic score (RES)
Time frame: 6 months
RES evaluated five variables 6 months: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables. The ideal esthetic score was 10. Zero points were assigned if the final position of the gingival margin was equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ. Zero points were also assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment
1 secondary outcome
recession depth
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Undecided. all the study records may be shared except that include participant name or personal information identifiers
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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 group A (Tunnel procedure with subepithelial connective tissue graft (sCTG) and group B (Tunnel procedure with modified free gingival graft (mFGG)) 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 4 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 5 Sep 2018. 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?
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?
root coverage aesthetic score (RES) (time frame: 6 months). 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 5 Sep 2018.