Interdental Papilla RecessionNCT06264869
Interdental Guided Creeping Technique
A study testing Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) and Interdental guided creeping technique (IGCT) and collagen membrane (CM) in people with Interdental Papilla Recession, run by October 6 University.
Trial summary
The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Interdental Papilla Recession
- What is being tested?
- Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) and Interdental guided creeping technique (IGCT) and collagen membrane (CM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients having interdental papilla deficiency.
- Good Oral Hygiene.
- Age range: 18 - 50 years.
Who cannot join
- Pregnancy or lactation.
- Smokers.
- Alcoholic patients and drug abusers.
- Handicapped and prisoners.
Trial locations and contacts
No sites are listed yet.
A.GamalElDin contact
About this study
Official title: A Novel Approach of Interdental Guided Creeping Technique (IGCT) for Augmentation of Deficient Interdental Papillae: Randomized Clinical Trial
The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.
- Conditions
- Interdental Papilla Recession
- Being tested
- Interdental guided creeping technique (IGCT) and connective tissue graft (CTG), Interdental guided creeping technique (IGCT) and collagen membrane (CM)
- Keywords
- Interdental papilla loss, Interdental papilla deficiency, Interdental papilla recession, Black triangle, Connective tissue graft, Collagen membrane, Minimally Invasive Surgery, Tunneling Techniques, Creeping Attachment, Plastic periodontal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)Procedure or surgery
Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)
Interdental guided creeping technique (IGCT) and collagen membrane (CM)Procedure or surgery
Interdental guided creeping technique (IGCT) and collagen membrane (CM)
| Study group | Role | What they receive |
|---|---|---|
| IGCT + CTG | Experimental | Interdental guided creeping technique (IGCT) + Connective tissue graft (CTG) Receives: Procedure: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) |
| IGCT + CM | Experimental | Interdental guided creeping technique (IGCT) + Collagen membrane (CM) Receives: Procedure: Interdental guided creeping technique (IGCT) and collagen membrane (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Black triangle height
In mm
Measured: Baseline, 1, 3 and 6 months.
Secondary outcomes (9)
Percentage of interdental papillary fill
In %
Measured: Baseline, 1, 3 and 6 months.
Papillary gain, black triangle reduction
In mm, %
Measured: Baseline, 1, 3 and 6 months.
Papillary height, attached gingiva width
In mm
Measured: Baseline, 1, 3 and 6 months.
Pocket depth, clinical attachment level, keratinized tissue thickness
In mm
Measured: Baseline, 3 and 6 months.
Plaque index
Scores
Measured: Baseline, 1, 3 and 6 months.
Gingival index
Scores
Measured: Baseline, 1, 3 and 6 months.
Duration of surgery
In minutes
Measured: At time of surgery
Patient Reported Outcome
VAS score for pain
Measured: At the day of surgery and the 1st 10 days postoperative.
Patient Reported Outcome
Patient satisfaction (score)
Measured: 1, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdental Papilla RecessionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Y Gamal, Ain Shams University
- Investigators
- Ghada G A.GamalElDin, Dr., Principal investigator, PhD Student of Periodontology, Faculty of Dentistry, Cairo UniversityMohamed S. Morgan, Dr., Principal investigator, Master Student of Periodontology, Faculty of Dentistry, Ain Shams UniversityAhmed Y Gamal, Prof., Study director, Professor of Oral Medicine, Periodontology and Oral Diagnosis - Faculty of Dentistry - Ain Shams University, Professor of Periodontology - College of Oral and Dental Surgery - Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264869
- Sponsor's protocol ID
- 141123
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 20 Feb 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach of Interdental Guided Creeping Technique (IGCT) for Augmentation of Deficient Interdental Papillae: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06264869
- Acronym / sponsor ID
- 141123
- Conditions
- Interdental Papilla Recession
- Keywords
- Interdental papilla loss, Interdental papilla deficiency, Interdental papilla recession, Black triangle, Connective tissue graft, Collagen membrane, Minimally Invasive Surgery, Tunneling Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 20 Feb 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.
The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGCT + CTG | Experimental | Procedure: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)Interdental guided creeping technique (IGCT) + Connective tissue graft (CTG) |
| IGCT + CM | Experimental | Procedure: Interdental guided creeping technique (IGCT) and collagen membrane (CM)Interdental guided creeping technique (IGCT) + Collagen membrane (CM) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy patients having interdental papilla deficiency.
- Good Oral Hygiene.
- Age range: 18 - 50 years.
Key exclusion criteria (4 listed)
- Pregnancy or lactation.
- Smokers.
- Alcoholic patients and drug abusers.
- Handicapped and prisoners.
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 |
|---|---|---|
| Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) | Procedure or surgery | IGCT + CTG |
| Interdental guided creeping technique (IGCT) and collagen membrane (CM)Interdental guided creeping technique (IGCT) and collagen membrane (CM) | Procedure or surgery | IGCT + CM |
Primary outcome
Black triangle height
Time frame: Baseline, 1, 3 and 6 months.
In mm
9 secondary outcomes
Percentage of interdental papillary fill
Time frame: Baseline, 1, 3 and 6 months.
Papillary gain, black triangle reduction
Time frame: Baseline, 1, 3 and 6 months.
Papillary height, attached gingiva width
Time frame: Baseline, 1, 3 and 6 months.
Pocket depth, clinical attachment level, keratinized tissue thickness
Time frame: Baseline, 3 and 6 months.
Plaque index
Time frame: Baseline, 1, 3 and 6 months.
Gingival index
Time frame: Baseline, 1, 3 and 6 months.
Duration of surgery
Time frame: At time of surgery
Patient Reported Outcome
Time frame: At the day of surgery and the 1st 10 days postoperative.
Patient Reported Outcome
Time frame: 1, 3 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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.
A.GamalElDin contact
Ghada G A.GamalElDin, Dr. principal investigator
PhD Student of Periodontology, Faculty of Dentistry, Cairo University
Mohamed S. Morgan, Dr. principal investigator
Master Student of Periodontology, Faculty of Dentistry, Ain Shams University
Ahmed Y Gamal, Prof. study director
Professor of Oral Medicine, Periodontology and Oral Diagnosis - Faculty of Dentistry - Ain Shams University, Professor of Periodontology - College of Oral and Dental Surgery - Misr University for Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) and Interdental guided creeping technique (IGCT) and collagen membrane (CM) in people with Interdental Papilla Recession, run by October 6 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 3 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 20 Feb 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?
Contact Gamal (01006607176, hgamal1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Black triangle height (time frame: Baseline, 1, 3 and 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 20 Feb 2024.