Gingival RecessionNCT06529640
Periosteal Pedicle Flap Versus Subepithelial Connective Tissue Graft in Management of Gingival Recession
A study testing SCTG followed by coronally postionting flap and periosteal flap followed by coronally postionting flap in people with Gingival Recession, run by Assiut University.
Trial summary
Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the… 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?
- SCTG followed by coronally postionting flap and periosteal flap followed by coronally postionting flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Nov 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
- age from 18 th 60 years.
Who cannot join
- Smokers
- patients with malposed or crowded teeth
- pregnant and lactating women
- patients using medications that could affect the periodontal status
About this study
Official title: Can a Periosteal Pedicle Flap Replace the Subepithelial Connective Tissue Graft in the Management of Gingival Recession? Randomized Controlled Clinical Trial
Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.
- Conditions
- Gingival Recession
- Being tested
- SCTG followed by coronally postionting flap, periosteal flap followed by coronally postionting flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTG followed by coronally postionting flapProcedure or surgery
The SCTG will be harvested from the palate followed by coronally postionting flap
periosteal flap followed by coronally postionting flapProcedure or surgery
he periosteal pedicle graft obtained is then turned over the exposed root surface then followed by coronally postionting flap
| Study group | Role | What they receive |
|---|---|---|
| Subepothelial connective tissue graft (SCTG) group | Active comparator | Subepithelial connective tissue graft from palate then coronally positioning flap to cover root recession Receives: Procedure: SCTG followed by coronally postionting flap |
| Periosteal pedicle flap (PPF) group | Active comparator | periosteal flap elevation and repositioning to the root then coronally positioning flap to cover root recession Receives: Procedure: periosteal flap followed by coronally postionting flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of root coverage (%RC)
to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100
Measured: at base line, 1 month and 3 months after treatment
Secondary outcomes (4)
recession depth
to measure vertical recession by UNC periodontal probe from cemento-enamel junction (CEJ) to the gingival margin.
Measured: at base line, 1 month and 3 months after treatment
recession width
to measure horizontal recession by UNC periodontal probe the distance between the CEJ and the gingival margin
Measured: at base line, 1 month and 3 months after treatment
clinical attachment gain
to measure the periodontal attachment gain after treatment by UNC periodontal probe subtracting the sulcus depth from the distance between the free gingival margin and the mucogingival junction.
Measured: at base line, 1 month and 3 months after treatment
keratinized tissue gain
measure the gain in keratinized gingivaby UNC periodontal probe from the most apical point of the gingival margin to the mucogingival junction (MGJ) at the middle buccal point.
Measured: at base line, 1 month and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (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 Assiut 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Alghriany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529640
- Sponsor's protocol ID
- periosteal pedicle flap
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Periosteal Pedicle Flap Replace the Subepithelial Connective Tissue Graft in the Management of Gingival Recession? Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06529640
- Acronym / sponsor ID
- periosteal pedicle flap
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 31 Jul 2024 (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.
Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subepothelial connective tissue graft (SCTG) group | Active comparator | Procedure: SCTG followed by coronally postionting flapSubepithelial connective tissue graft from palate then coronally positioning flap to cover root recession |
| Periosteal pedicle flap (PPF) group | Active comparator | Procedure: periosteal flap followed by coronally postionting flapperiosteal flap elevation and repositioning to the root then coronally positioning flap to cover root recession |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
- age from 18 th 60 years.
Key exclusion criteria (4 listed)
- Smokers
- patients with malposed or crowded teeth
- pregnant and lactating women
- patients using medications that could affect the periodontal status
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 |
|---|---|---|
| SCTG followed by coronally postionting flapThe SCTG will be harvested from the palate followed by coronally postionting flap | Procedure or surgery | Subepothelial connective tissue graft (SCTG) group |
| periosteal flap followed by coronally postionting flaphe periosteal pedicle graft obtained is then turned over the exposed root surface then followed by coronally postionting flap | Procedure or surgery | Periosteal pedicle flap (PPF) group |
Primary outcome
the percentage of root coverage (%RC)
Time frame: at base line, 1 month and 3 months after treatment
to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100
4 secondary outcomes
recession depth
Time frame: at base line, 1 month and 3 months after treatment
recession width
Time frame: at base line, 1 month and 3 months after treatment
clinical attachment gain
Time frame: at base line, 1 month and 3 months after treatment
keratinized tissue gain
Time frame: at base line, 1 month and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing SCTG followed by coronally postionting flap and periosteal flap followed by coronally postionting flap in people with Gingival Recession, run by Assiut 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 2 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 31 Jul 2024. 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 percentage of root coverage (%RC) (time frame: at base line, 1 month and 3 months after treatment). 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 31 Jul 2024.