Recession, GingivalNCT05823415
Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession
A study testing Laterally Closed Tunnel with CTG and CAF with CTG in people with Recession, Gingival, run by British University In Egypt.
Trial summary
The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- Laterally Closed Tunnel with CTG and CAF with CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket)
- Patients with good oral hygiene
- Medically free patients
- No signs of active periodontal disease (with no site showing probing depth > 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth).
- Palate with sufficient thickness to accommodate soft tissue defect.
Who cannot join
- Smokers
- Pregnancy
- Severe gag reflex
- Non-carious cervical lesion
- History of mucogingival or periodontal surgery at the experimental site
- History of medication that can affect periodontal healing
About this study
Official title: Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession: A Randomized Controlled Clinical Trial
The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.
- Conditions
- Recession, Gingival
- Being tested
- Laterally Closed Tunnel with CTG, CAF with CTG
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laterally Closed Tunnel with CTGProcedure or surgery
A novel minimally invasive surgical approach laterally closed tunnel technique (LCT) has been recently introduced for the management of isolated gingival recession. The laterally closed tunnel technique ensures predictability by tunneling and mobilization of flap for graft coverage.
CAF with CTGProcedure or surgery
Gold standard surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Laterally closed tunnel technique with CTG | Experimental | Not described Receives: Procedure: Laterally Closed Tunnel with CTG |
| Coronally advanced flap with CTG | Active comparator | Not described Receives: Procedure: CAF with CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in recession depth
Measured: 6 Months
Secondary outcomes (6)
Post-operative pain assessed by VAS Scale
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10, 0: no pain, 1: minimal pain 5: moderate pain, 10: severe pain)
Measured: 2 week
Probing Depth
Measured: 6 months
Clinical Attachment Level
will be measured by a periodontal probe
Measured: 6 months
Width of Keratinized Tissue
Measured: 6 months
Gingival Thickness
Measured: 6 months
Percentage of complete root coverage by williams periodontal probe
Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
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 posted21 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies of the same condition, open and under way.
- 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Rajab, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823415
- Sponsor's protocol ID
- 1241953
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05823415
- Acronym / sponsor ID
- 1241953
- Conditions
- Recession, Gingival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Apr 2023 (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 aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laterally closed tunnel technique with CTG | Experimental | Procedure: Laterally Closed Tunnel with CTG |
| Coronally advanced flap with CTG | Active comparator | Procedure: CAF with CTG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket)
- Patients with good oral hygiene
- Medically free patients
- No signs of active periodontal disease (with no site showing probing depth > 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth).
- Palate with sufficient thickness to accommodate soft tissue defect.
Key exclusion criteria (6 listed)
- Smokers
- Pregnancy
- Severe gag reflex
- Non-carious cervical lesion
- History of mucogingival or periodontal surgery at the experimental site
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 |
|---|---|---|
| Laterally Closed Tunnel with CTGA novel minimally invasive surgical approach laterally closed tunnel technique (LCT) has been recently introduced for the management of isolated gingival recession. The laterally closed tunnel technique ensures predictability by tunneling and mobilization of flap for graft coverage. | Procedure or surgery | Laterally closed tunnel technique with CTG |
| CAF with CTGGold standard surgical technique | Procedure or surgery | Coronally advanced flap with CTG |
Primary outcome
Reduction in recession depth
Time frame: 6 Months
6 secondary outcomes
Post-operative pain assessed by VAS Scale
Time frame: 2 week
Probing Depth
Time frame: 6 months
Clinical Attachment Level
Time frame: 6 months
Width of Keratinized Tissue
Time frame: 6 months
Gingival Thickness
Time frame: 6 months
Percentage of complete root coverage by williams periodontal probe
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 21 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 Laterally Closed Tunnel with CTG and CAF with CTG in people with Recession, Gingival, run by British University 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 5 inclusion and 6 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 21 Apr 2023. 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?
Reduction in recession depth (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 21 Apr 2023.