Gingival RecessionNCT06842290
Effect of Botulinum Toxin a Injection in Treatment of Recession RT1 and RT2
A study testing Botulinum toxin-A injection and Coronally advanced flap in people with Gingival Recession, run by Cairo University.
Trial summary
The goal of this study type: clinical trial] is to learn the effect of Botulinum Toxin _A injection in treatment of RT1andRT2 Gingival recession in lower anterior teeth . Primary outcome is keratinzed tissue width. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Botulinum toxin-A injection and Coronally advanced flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2025to 16 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single or multiple RT1, RT2 GR patient
- patients ≥18 years
- systemically healthy, full mouth plaque score, full mouth bleeding score ≤ 15% after phase I therapy
- clinical indication and/or patient request for recession coverage
- well motivated patients, maintaining oral hygiene throughout study
Who cannot join
- Pregnant or lactating women
- Smokers' patients
- Teeth with cervical restorations/abrasion.
- Patients had a systemic condition affect blood components and healing
About this study
Official title: Effect of Botulinum Toxin -A Injection in Mentalis Muscle with Coronally Advanced Flap and De-epithelized Free Gingival Graft in Treatment of RT1 , RT2 Gingival Recession _Randomized Control Trial
The goal of this study type: clinical trial] is to learn the effect of Botulinum Toxin _A injection in treatment of RT1andRT2 Gingival recession in lower anterior teeth .
Primary outcome is keratinzed tissue width. Researchers will compare Coronally Advanced flap with De-epithelized free gingival graft and Botulinum toxin-A injection in Mentalis muscle with coronally advanced flap with De-epithelized free gingival graft alone .
The outcome will be measured at baseline, after 3 months and after 6 mobths _medical history
- 3 mm horizontal incisions, then two vertical incisions
- deepitheliztion of anatomical papillae
- superficial and deep incisions
- harvesting DFGG
- Suturing
- BOTOX injection
- Conditions
- Gingival Recession
- Being tested
- Botulinum toxin-A injection, Coronally advanced 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.
Botulinum toxin-A injectionProcedure or surgery
Botulinum toxin-A Injection Mentalis muscle in lower anterior teeth
Coronally advanced flapProcedure or surgery
Coronally Advanced Flap andDe-epithelized Free Gingival Graft
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | In this arm principal investigator will preform coronally advanced flap with De-epithelized free gingival graft then will inject Botulinum toxin-A in Mentalis muscle after suturing Receives: Procedure: Botulinum toxin-A injection |
| Control arm | Active comparator | In this arm no injection will be applied only coronally advanced flap with De-epithelized free gingival graft alone Receives: Procedure: Coronally advanced flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized tissue width
Measured: Measured at baseline ,3months ,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start4 Apr 2025 (estimated)
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Oct 2026 (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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Mostafa Tawfik Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842290
- Sponsor's protocol ID
- PER3,3,2
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Botulinum Toxin -A Injection in Mentalis Muscle with Coronally Advanced Flap and De-epithelized Free Gingival Graft in Treatment of RT1 , RT2 Gingival Recession _Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06842290
- Acronym / sponsor ID
- PER3,3,2
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Apr 2025 (estimated)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 24 Feb 2025 (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.
The goal of this study type: clinical trial] is to learn the effect of Botulinum Toxin _A injection in treatment of RT1andRT2 Gingival recession in lower anterior teeth .
Primary outcome is keratinzed tissue width. Researchers will compare Coronally Advanced flap with De-epithelized free gingival graft and Botulinum toxin-A injection in Mentalis muscle with coronally advanced flap with De-epithelized free gingival graft alone .
The outcome will be measured at baseline, after 3 months and after 6 mobths _medical history
- 3 mm horizontal incisions, then two vertical incisions
- deepitheliztion of anatomical papillae
- superficial and deep incisions
- harvesting DFGG
- Suturing
- BOTOX injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: Botulinum toxin-A injectionIn this arm principal investigator will preform coronally advanced flap with De-epithelized free gingival graft then will inject Botulinum toxin-A in Mentalis muscle after suturing |
| Control arm | Active comparator | Procedure: Coronally advanced flapIn this arm no injection will be applied only coronally advanced flap with De-epithelized free gingival graft alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Single or multiple RT1, RT2 GR patient
- patients ≥18 years
- systemically healthy, full mouth plaque score, full mouth bleeding score ≤ 15% after phase I therapy
- clinical indication and/or patient request for recession coverage
- well motivated patients, maintaining oral hygiene throughout study
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Smokers' patients
- Teeth with cervical restorations/abrasion.
- Patients had a systemic condition affect blood components and 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 |
|---|---|---|
| Botulinum toxin-A injectionBotulinum toxin-A Injection Mentalis muscle in lower anterior teeth | Procedure or surgery | Intervention arm |
| Coronally advanced flapCoronally Advanced Flap andDe-epithelized Free Gingival Graft | Procedure or surgery | Control arm |
Primary outcome
Keratinized tissue width
Time frame: Measured at baseline ,3months ,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
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 Botulinum toxin-A injection and Coronally advanced flap in people with Gingival Recession, run by Cairo 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 5 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: opening soon, as of the sponsor's last update on 25 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Keratinized tissue width (time frame: Measured at baseline ,3months ,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 25 Feb 2025.