Gingival RecessionEarly Phase 1RCTNCT04849663
Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft
A Early Phase 1 study testing free fat graft and subepithelial graft in people with Gingival Recession, run by Ain Shams University at 1 site in Egypt.
Trial summary
Compare between Buccal fat pad and subepithelial connective tissue graft in treatment of localized recession. Primary objective: to evaluate root coverage in terms of gingival thickness and esthetic. Secondary objective: to evaluate patient satisfaction and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- free fat graft and subepithelial graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2018to 24 Jan 2021
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should be above 18 years.
- Patient included in the study will be with Miller class II recession defect.
- Patient having at least 1 mm of residual keratinized tissue.
Who cannot join
- Patient with Systemic Problem affecting the results of periodontal Therapy.
- Patients having allergy to drugs.
- Pregnant women.
- Patients with any smoking habits.
- Patients having bleeding problems or on anticoagulant therapy.
- Patients having caries or restorations in relation to the treated site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft in the Treatment of Localized Recession (Randomized Clinical Trial)
Compare between Buccal fat pad and subepithelial connective tissue graft in treatment of localized recession.
Primary objective: to evaluate root coverage in terms of gingival thickness and esthetic.
Secondary objective: to evaluate patient satisfaction and postoperative pain.
Read the detailed description
Material and Methods
16 patients from outpatient Oral Diagnosis dental clinic will participate in this study.
Patient selection and hospitalization
Prospective randomized clinical trial will be conducted on patients requiring correction of gingival recession. The research will be reviewed by the ethical committee of Faculty of Dentistry Ain Shams University.
Patient Grouping
Patient will be randomly allocated into one of the two groups:
control group (8 patients): will be treated with coronally advanced flap combined with subepithelial Connective tissue graft (SCTG).
Study group(8 patients): will be treated with coronally advanced flap combined with buccal fat pad (BFP).
Preoperative Assessment
For all patients routine radiographic investigations are required. The first phase of therapy formed of oral hygiene measures, scaling, subgingival debridement and correction of any disturbance in occlusion needed. A periodontal evaluation should be done two weeks after phase I therapy.
A stent will be made for each defect with vertical groove located at the mid-labial region to standardize the placement and angulation of probe while taking measurement. All measurements will be taken with a standardized Williams graduated periodontal probe (Hu-Friedy).
Surgical procedure:
- Oral antiseptic mouthwash will be used before anaesthetizing the surgical area. A field block anesthesia at the surgical area is given with a lidocaine and epinephrine-containing solution.
- Recipient site preparation
- A split-thickness flap will be reflected by a horizontal incision made at the papilla base, mesial and distal to the recession defects. Two slightly divergent incisions will be released from the end of the previous horizontal incisions with a full-thickness flap starting from margin of the gingiva reaching 3-4 mm after the exposed bone then continue with a split-thickness extending to the alveolar mucosa .
- After flap elevation scaling, planing of the exposed root followed by root conditioning with a tetracycline solution (125 mg tetracycline/ml of saline). In the study group sites, previously prepared BFP or a subepihelial CT graft in control group will be applied over the exposed root a single sling suture will fix the flap just coronal to the Cemento-enamel junction (CEJ). Flaps will also be coronally positioned.
- Donor site:
- In study group the buccal vestibule is anesthetized in vicinity of the first and second maxillary molar. The cheek will be retracted laterally and a mucosal incision will be made while leaving a cuff of non- attached mucosa for closure. The incision will be done throughout the mucosa and muscle meanwhile an external pressure will be applied on the skin in the area of the buccal fat pad. After the buccal fat pad exposure, the fascia is pierced with scissors. With a continuous external pressure on the cheeck a long hemostat is used to spread and manipulate the fat. With minimal delicate traction, the protruding portion of the fat pad is gently grasped and pulled outside of the incision then the fat is clamped at the base and the required amount is harvested and excised to be used in donor site. The incision is closed with suture .
- The control group will receive SCTG from the palate with a single incision technique .
Postoperatively patients will be covered by Augmentine 1 gm tablets every 12 hours and flagyl 500 mg every eight hours. Analgesics are given in a combined protocol; where ibuprofen 600mg and paracetamol 1gm are alternating. The patient is instructed to use 0.12% chlorhexidine mouthwash three times daily for two weeks.
Methods of assessment
The parameters which should be measured at baseline, 3 and 6 months after surgery:
- Plaque index (PI) will be recorded according to Silness and Loe .
- Gingival index (GI) will be recorded according to Loe and Silness .
- Probing depth (PD).
- Clinical attachment level (CAL).
- Recession depth (RD).
- Recession width (RW).
- Percentage of mean root coverage (MRC %) will be calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
- Width of keratinized tissue (WKT).
- Gingival thickness (GTH).
- Root coverage esthetic score (RES).
- Pain level will be assessed by verbal, numeric scale and by recording amount of analgesic intake postoperatively.
Result presentation and statistics
Results will be tabulated and statistically analyzed.
- Conditions
- Gingival Recession
- Being tested
- free fat graft, subepithelial 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.
free fat graftBiological
fat harvested from patient will be used to cover exposed root
subepithelial graftBiological
subepitheial graft harvested from palate
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Use of free fat graft to cover exposed root Receives: Biological: free fat graft |
| control group | Active comparator | use of sub epithelial connective tissue graft to cover exposed root Receives: Biological: subepithelial graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of root coverage esthetic score
evaluation of root gingival coverage after modified Coronally advanced flap the scale is from 1-4 ... based on degree of coverage the score will be given 1=1005, 2=75%, 3=50%, 4=25%
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 posted19 Apr 2021
- Study start24 Jun 2018
- Primary completion24 Jan 2021
- Study completion24 Jan 2021
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 Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shehad wael, Ain Shams University
- Investigators
- shehad wael, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849663
- Sponsor's protocol ID
- ASU689
- Acronym
- RCT
- Status last verified
- Jan 2022
- First submitted
- 31 Mar 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft in the Treatment of Localized Recession (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04849663
- Acronym / sponsor ID
- RCT / ASU689
- Conditions
- Gingival Recession
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Jun 2018 (actual)
- Primary completion
- 24 Jan 2021 (actual)
- Study completion
- 24 Jan 2021 (actual)
- First posted
- 19 Apr 2021 (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.
Compare between Buccal fat pad and subepithelial connective tissue graft in treatment of localized recession.
Primary objective: to evaluate root coverage in terms of gingival thickness and esthetic.
Secondary objective: to evaluate patient satisfaction and postoperative pain.
Detailed description
Material and Methods
16 patients from outpatient Oral Diagnosis dental clinic will participate in this study.
Patient selection and hospitalization
Prospective randomized clinical trial will be conducted on patients requiring correction of gingival recession. The research will be reviewed by the ethical committee of Faculty of Dentistry Ain Shams University.
Patient Grouping
Patient will be randomly allocated into one of the two groups:
control group (8 patients): will be treated with coronally advanced flap combined with subepithelial Connective tissue graft (SCTG).
Study group(8 patients): will be treated with coronally advanced flap combined with buccal fat pad (BFP).
Preoperative Assessment
For all patients routine radiographic investigations are required. The first phase of therapy formed of oral hygiene measures, scaling, subgingival debridement and correction of any disturbance in occlusion needed. A periodontal evaluation should be done two weeks after phase I therapy.
A stent will be made for each defect with vertical groove located at the mid-labial region to standardize the placement and angulation of probe while taking measurement. All measurements will be taken with a standardized Williams graduated periodontal probe (Hu-Friedy).
Surgical procedure:
- Oral antiseptic mouthwash will be used before anaesthetizing the surgical area. A field block anesthesia at the surgical area is given with a lidocaine and epinephrine-containing solution.
- Recipient site preparation
- A split-thickness flap will be reflected by a horizontal incision made at the papilla base, mesial and distal to the recession defects. Two slightly divergent incisions will be released from the end of the previous horizontal incisions with a full-thickness flap starting from margin of the gingiva reaching 3-4 mm after the exposed bone then continue with a split-thickness extending to the alveolar mucosa .
- After flap elevation scaling, planing of the exposed root followed by root conditioning with a tetracycline solution (125 mg tetracycline/ml of saline). In the study group sites, previously prepared BFP or a subepihelial CT graft in control group will be applied over the exposed root a single sling suture will fix the flap just coronal to the Cemento-enamel junction (CEJ). Flaps will also be coronally positioned.
- Donor site:
- In study group the buccal vestibule is anesthetized in vicinity of the first and second maxillary molar. The cheek will be retracted laterally and a mucosal incision will be made while leaving a cuff of non- attached mucosa for closure. The incision will be done throughout the mucosa and muscle meanwhile an external pressure will be applied on the skin in the area of the buccal fat pad. After the buccal fat pad exposure, the fascia is pierced with scissors. With a continuous external pressure on the cheeck a long hemostat is used to spread and manipulate the fat. With minimal delicate traction, the protruding portion of the fat pad is gently grasped and pulled outside of the incision then the fat is clamped at the base and the required amount is harvested and excised to be used in donor site. The incision is closed with suture .
- The control group will receive SCTG from the palate with a single incision technique .
Postoperatively patients will be covered by Augmentine 1 gm tablets every 12 hours and flagyl 500 mg every eight hours. Analgesics are given in a combined protocol; where ibuprofen 600mg and paracetamol 1gm are alternating. The patient is instructed to use 0.12% chlorhexidine mouthwash three times daily for two weeks.
Methods of assessment
The parameters which should be measured at baseline, 3 and 6 months after surgery:
- Plaque index (PI) will be recorded according to Silness and Loe .
- Gingival index (GI) will be recorded according to Loe and Silness .
- Probing depth (PD).
- Clinical attachment level (CAL).
- Recession depth (RD).
- Recession width (RW).
- Percentage of mean root coverage (MRC %) will be calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
- Width of keratinized tissue (WKT).
- Gingival thickness (GTH).
- Root coverage esthetic score (RES).
- Pain level will be assessed by verbal, numeric scale and by recording amount of analgesic intake postoperatively.
Result presentation and statistics
Results will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Biological: free fat graftUse of free fat graft to cover exposed root |
| control group | Active comparator | Biological: subepithelial graftuse of sub epithelial connective tissue graft to cover exposed root |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should be above 18 years.
- Patient included in the study will be with Miller class II recession defect.
- Patient having at least 1 mm of residual keratinized tissue.
Key exclusion criteria (6 listed)
- Patient with Systemic Problem affecting the results of periodontal Therapy.
- Patients having allergy to drugs.
- Pregnant women.
- Patients with any smoking habits.
- Patients having bleeding problems or on anticoagulant therapy.
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 |
|---|---|---|
| free fat graftfat harvested from patient will be used to cover exposed root | Biological | study group |
| subepithelial graftsubepitheial graft harvested from palate | Biological | control group |
Primary outcome
evaluation of root coverage esthetic score
Time frame: 6 months
evaluation of root gingival coverage after modified Coronally advanced flap the scale is from 1-4 ... based on degree of coverage the score will be given 1=1005, 2=75%, 3=50%, 4=25%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
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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.
shehad wael principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing free fat graft and subepithelial graft in people with Gingival Recession, run by Ain Shams University at 1 site 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 3 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: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
evaluation of root coverage esthetic score (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 14 Feb 2022.