Gingival RecessionNCT03543163
Treatment of Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft
A study testing Non- Pedicled Buccal Fat Pad with Coronally Advanced flap and sub-epithelial connective tissue graft in people with Gingival Recession, run by Cairo University.
Trial summary
This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Non- Pedicled Buccal Fat Pad with Coronally Advanced flap and sub-epithelial connective tissue graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are systemically healthy based on questionnaire dental modification of Cornell index.
- Patients are periodontally healthy with no contraindication for periodontal surgery.
- All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
- O'Leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation)
- Buccal recession defects are classified as Miller Class I or II.
- Presence of identifiable CEJ.
- The papilla fill the interdental spaces as far as the contact area
- Clinical indication and/or patient request for recession coverage.
Who cannot join
- Miller Class III or IV recession defects
- Pregnant female.
- Smokers as smoking is contraindicated for any plastic periodontal surgery
- Patients with special needs or with any mental problems.
- Patients undergoing radiotherapy
- Teeth with carious or non-carious lesion or cervical restorations
- Rotated teeth and tooth extrusion with or without occlusal abrasion
- Patient undergone any prior periodontal surgery in the relevant region.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Evaluation of Recession Depth After Treating Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft. A Randomized Controlled Clinical Trial
This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II gingival recession
- Conditions
- Gingival Recession
- Being tested
- Non- Pedicled Buccal Fat Pad with Coronally Advanced flap, sub-epithelial connective tissue graft
- Keywords
- buccal fat pad graft, sub-epithelial connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- Pedicled Buccal Fat Pad with Coronally Advanced flapProcedure or surgery
A horizontal incision of 1.5cm in long will be made at the bottom of the vestibule with the #15 blade in the region of maxillary first and second molars, depending on side of the recipient site. A curved hemostat will be used in the blunt dissection through the buccinators muscle to temporarily reposition and loose the surrounding fascia which will allow the buccal fat pad to be exposed in the oral cavity. A portion of adipose tissue equals to the required graft size will be excised with the microsurgical scissors. The grafting material will be placed on a saline-soaked gauze until its transfer to the recipient site. Finally, the patient's check will be compressed, in order to promote the closure of the wound edges then immediately close the donor site with simple 5.0 silk thread interrupted sutures
sub-epithelial connective tissue graftProcedure or surgery
a sub- epithelial connective tissue graft is harvested from the hard palate is used to treat area with gingival recession
| Study group | Role | What they receive |
|---|---|---|
| subepithelial connective tissue graft | Active comparator | Subepithelial Connective Tissue graft from the hard palate with Coronally Advanced flap at the site of gingival recession. Receives: Procedure: sub-epithelial connective tissue graft |
| non pedicled buccal fat pad graft | Experimental | Non- Pedicled Buccal Fat Pad with Coronally Advanced flap at the site of gingival recession Receives: Procedure: Non- Pedicled Buccal Fat Pad with Coronally Advanced flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Depth
Measured from the CEJ to the most apical extension of the gingival margin using the UNC-15 periodontal probe and measured in mm unit
Measured: 6 months
Secondary outcomes (2)
Thickness of keratinized tissue
Evaluation of the gingival thickness by trans-gingival piercing using an anesthetic needle with a silicon stopper inserted perpendicular to the mucosal surface with light pressure until touching a hard surface and the silicon disk in a tight contact with soft tissue surface. This measurement should be taken 1.5 mm apical from the gingival margin. Then the correct position of the disk is fixed with a drop of cyanoacrylic adhesive after careful removal of the needle. The penetration depth is measured by an accurate caliper
Measured: 6 months
Post-operative pain
Visual Analogue Scale (VAS) with numbers from 0 to 100 ('no pain' to 'worst pain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Sep 2021 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2025 (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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia Emad Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543163
- Sponsor's protocol ID
- CEBD-CU-2018-05-15
- Status last verified
- Oct 2019
- First submitted
- 19 May 2018
- Last updated
- 15 Oct 2019
- 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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Recession Depth After Treating Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03543163
- Acronym / sponsor ID
- CEBD-CU-2018-05-15
- Conditions
- Gingival Recession
- Keywords
- buccal fat pad graft, sub-epithelial connective tissue graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Jun 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.
This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II gingival recession
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subepithelial connective tissue graft | Active comparator | Procedure: sub-epithelial connective tissue graftSubepithelial Connective Tissue graft from the hard palate with Coronally Advanced flap at the site of gingival recession. |
| non pedicled buccal fat pad graft | Experimental | Procedure: Non- Pedicled Buccal Fat Pad with Coronally Advanced flapNon- Pedicled Buccal Fat Pad with Coronally Advanced flap at the site of gingival recession |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients are systemically healthy based on questionnaire dental modification of Cornell index.
- Patients are periodontally healthy with no contraindication for periodontal surgery.
- All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
- O'Leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation)
- Buccal recession defects are classified as Miller Class I or II.
Key exclusion criteria (8 listed)
- Miller Class III or IV recession defects
- Pregnant female.
- Smokers as smoking is contraindicated for any plastic periodontal surgery
- Patients with special needs or with any mental problems.
- Patients undergoing radiotherapy
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 |
|---|---|---|
| Non- Pedicled Buccal Fat Pad with Coronally Advanced flapA horizontal incision of 1.5cm in long will be made at the bottom of the vestibule with the #15 blade in the region of maxillary first and second molars, depending on side of the recipient site. A curved hemostat will be used in the blunt dissection through the buccinators muscle to temporarily reposition and loose the surrounding fascia which will allow the buccal fat pad to be exposed in the oral cavity. A portion of adipose tissue equals to the required graft size will be excised with the microsurgical scissors. The grafting material will be placed on a saline-soaked gauze until its transfer to the recipient site. Finally, the patient's check will be compressed, in order to promote the closure of the wound edges then immediately close the donor site with simple 5.0 silk thread interrupted sutures | Procedure or surgery | non pedicled buccal fat pad graft |
| sub-epithelial connective tissue grafta sub- epithelial connective tissue graft is harvested from the hard palate is used to treat area with gingival recession | Procedure or surgery | subepithelial connective tissue graft |
Primary outcome
Recession Depth
Time frame: 6 months
Measured from the CEJ to the most apical extension of the gingival margin using the UNC-15 periodontal probe and measured in mm unit
2 secondary outcomes
Thickness of keratinized tissue
Time frame: 6 months
Post-operative pain
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Non- Pedicled Buccal Fat Pad with Coronally Advanced flap and sub-epithelial connective tissue graft 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 8 inclusion and 8 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 15 Oct 2019. 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 alia emad (01123155050, aliaemad6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 15 Oct 2019.