Gingival RecessionNCT03213483
Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.
A study testing Coronally advanced flap and subepithelial connective tissue graft and Coronally advanced flap and deepithelialized free gingival graft in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and… 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?
- Coronally advanced flap and subepithelial connective tissue graft and Coronally advanced flap and deepithelialized free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2017to 27 Jul 2019
- 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 18 years or older.
- Periodontally and systemically healthy.
- Buccal recession defects classified as either Miller class I or II.
- Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010).
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20% (O'Leary et al., 1972).
Who cannot join
- Miller class III or IV recession defects.
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Teeth with cervical restorations, abrasion.
- Presence of systemic disease that would affect wound healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Controlled Clinical Trial
The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.
Read the detailed description
Evidence from the literature showed that coronally advanced flap was a predictable method for root coverage. The addition of a connective tissue graft was also found to improve the outcome of obtaining complete root coverage in Miller class I and II gingival recession. Many different connective tissue graft-harvesting techniques have been utilized. These techniques aimed at reducing patient morbidity by primary closure of the palatal flap to achieve primary intention wound healing. However, they had the limitation of requiring an adequate thickness of the palatal fibromucosa in order to prevent desquamation of the undermined flap and compromised vasculature.
On the other hand, the free gingival graft surgical technique was also unaccepted esthetically due to the white scar and irregularities produced at the monolingual junction.
Moreover, despite the fact that the free gingival graft had its limitation of being associated with greater post-operative pain, discomfort and bleeding due to healing by secondary intention in 2-4 weeks, nevertheless, this technique was much easier to perform and could be used even in cases of thin palatal fibromucosa.
The evidence in literature comparing patient morbidity and root coverage outcomes between these two techniques is minimal. Studies by Griffin et al. (2006) and Wessel and Tatakis (2008) reported increased incidence of post-operative pain with free gingival grafts. However, a recently study by Zucchelli et al. (2010) compared post-operative morbidity and root coverage outcomes in patients treated with trap-door connective tissue graft and de-epithelialized free gingival graft found no statistically significant differences in pain killer consumption, post-operative discomfort and bleeding between the two groups.
Still very few studies measured the effect of different connective tissue graft harvesting techniques on gingival thickness. And even in the study by Zucchelli et al. (2010), only speculative explanation was given regarding the increase of gingival thickness in case of a de-epithelialized free gingival graft than subepithelial connective tissue graft.
Gingival thickness was proved to be an important factor for the etiology of gingival recession as thick gingival tissues are able to confine the inflammation within the region of the gingival sulcus and prevent its extension to destroy the outer gingival tissue leading to gingival recession.
Therefore, this study will monitor the effect of different connective tissue harvesting techniques (De-epithelialized free gingival graft versus subepithelial connective tissue graft) on gingival thickness enhancement. It will also evaluate the de-epithelialized free gingival graft as a harvesting mechanism for connective tissue graft in terms of patient morbidity and root coverage outcomes.
- Conditions
- Gingival Recession
- Being tested
- Coronally advanced flap and subepithelial connective tissue graft, Coronally advanced flap and deepithelialized free gingival graft
- Keywords
- gingival recession, connective tissue graft, deepithelialized free gingival graft, free gingival 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.
Coronally advanced flap and subepithelial connective tissue graftProcedure or surgery
The connective tissue graft is obtained by a single line incision from the palate.
Coronally advanced flap and deepithelialized free gingival graftProcedure or surgery
The connective tissue graft is obtained by deepithelialization of a free gingival graft.
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial connective tissue graft | Active comparator | Patients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage. Receives: Procedure: Coronally advanced flap and subepithelial connective tissue graft |
| De-epithelialized free gingival graft | Experimental | Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage. Receives: Procedure: Coronally advanced flap and deepithelialized free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Thickness
Thickness of the gingival tissues 2 mm from the free gingival margin
Measured: 6 months
Secondary outcomes (7)
Percentage of root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Measured: 6 months
Root coverage esthetic score
A system proposed for evaluating esthetic outcomes of root coverage procedures.
Measured: 6 months
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively
Measured: Two weeks
Post-operative stress
level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing
Measured: Two weeks
Post-operative bleeding
prolonged hemorrhaging during the post-surgical week reported by the patients measured by a questionnaire as a categorical yes or no question.
Measured: Two weeks
Post-operative inability to chew
Will be described as the level of variation of the patient's eating habits due to the presence of the palatal wound.
Measured: Two weeks
Post-Surgical Patient Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.
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 posted11 Jul 2017
- Study start17 Oct 2017
- Primary completion27 May 2019
- Study completion27 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Parallel groups, randomized clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mashaly, Cairo University
- Investigators
- Azza Ezz Elarab, Phd, Study chair, ProfessorNoha Ghallab, Phd, Study director, ProfessorWeam El Battawy, Phd, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213483
- Sponsor's protocol ID
- Deepfggvsctg
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
PubMed 20590963
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03213483
- Acronym / sponsor ID
- Deepfggvsctg
- Conditions
- Gingival Recession
- Keywords
- gingival recession, connective tissue graft, deepithelialized free gingival graft, free gingival graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 Jul 2019 (actual)
- First posted
- 11 Jul 2017 (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 will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.
Detailed description
Evidence from the literature showed that coronally advanced flap was a predictable method for root coverage. The addition of a connective tissue graft was also found to improve the outcome of obtaining complete root coverage in Miller class I and II gingival recession. Many different connective tissue graft-harvesting techniques have been utilized. These techniques aimed at reducing patient morbidity by primary closure of the palatal flap to achieve primary intention wound healing. However, they had the limitation of requiring an adequate thickness of the palatal fibromucosa in order to prevent desquamation of the undermined flap and compromised vasculature.
On the other hand, the free gingival graft surgical technique was also unaccepted esthetically due to the white scar and irregularities produced at the monolingual junction.
Moreover, despite the fact that the free gingival graft had its limitation of being associated with greater post-operative pain, discomfort and bleeding due to healing by secondary intention in 2-4 weeks, nevertheless, this technique was much easier to perform and could be used even in cases of thin palatal fibromucosa.
The evidence in literature comparing patient morbidity and root coverage outcomes between these two techniques is minimal. Studies by Griffin et al. (2006) and Wessel and Tatakis (2008) reported increased incidence of post-operative pain with free gingival grafts. However, a recently study by Zucchelli et al. (2010) compared post-operative morbidity and root coverage outcomes in patients treated with trap-door connective tissue graft and de-epithelialized free gingival graft found no statistically significant differences in pain killer consumption, post-operative discomfort and bleeding between the two groups.
Still very few studies measured the effect of different connective tissue graft harvesting techniques on gingival thickness. And even in the study by Zucchelli et al. (2010), only speculative explanation was given regarding the increase of gingival thickness in case of a de-epithelialized free gingival graft than subepithelial connective tissue graft.
Gingival thickness was proved to be an important factor for the etiology of gingival recession as thick gingival tissues are able to confine the inflammation within the region of the gingival sulcus and prevent its extension to destroy the outer gingival tissue leading to gingival recession.
Therefore, this study will monitor the effect of different connective tissue harvesting techniques (De-epithelialized free gingival graft versus subepithelial connective tissue graft) on gingival thickness enhancement. It will also evaluate the de-epithelialized free gingival graft as a harvesting mechanism for connective tissue graft in terms of patient morbidity and root coverage outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel groups, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Subepithelial connective tissue graft | Active comparator | Procedure: Coronally advanced flap and subepithelial connective tissue graftPatients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage. |
| De-epithelialized free gingival graft | Experimental | Procedure: Coronally advanced flap and deepithelialized free gingival graftPatients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 years or older.
- Periodontally and systemically healthy.
- Buccal recession defects classified as either Miller class I or II.
- Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010).
- Clinical indication and/or patient request for recession coverage.
Key exclusion criteria (7 listed)
- Miller class III or IV recession defects.
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- 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 |
|---|---|---|
| Coronally advanced flap and subepithelial connective tissue graftThe connective tissue graft is obtained by a single line incision from the palate. | Procedure or surgery | Subepithelial connective tissue graft |
| Coronally advanced flap and deepithelialized free gingival graftThe connective tissue graft is obtained by deepithelialization of a free gingival graft. | Procedure or surgery | De-epithelialized free gingival graft |
Primary outcome
Gingival Thickness
Time frame: 6 months
Thickness of the gingival tissues 2 mm from the free gingival margin
7 secondary outcomes
Percentage of root coverage
Time frame: 6 months
Root coverage esthetic score
Time frame: 6 months
Post-Operative Pain
Time frame: Two weeks
Post-operative stress
Time frame: Two weeks
Post-operative bleeding
Time frame: Two weeks
Post-operative inability to chew
Time frame: Two weeks
Post-Surgical Patient Satisfaction
Time frame: 6 months
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 13 Aug 2019.
- Background: PubMed 20590963Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
- 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.
Azza Ezz Elarab, Phd study chair
Professor
Noha Ghallab, Phd study director
Professor
Weam El Battawy, Phd study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally advanced flap and subepithelial connective tissue graft and Coronally advanced flap and deepithelialized free gingival graft in people with Gingival Recession, run by Cairo 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 6 inclusion and 7 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 13 Aug 2019. 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.
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?
Gingival Thickness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03213483, which also lists 1 linked publication.
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 13 Aug 2019.