Gingival RecessionNCT02916186
Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions
A study testing Acellular Dermal Matrix and Tunnel technique with the subepithelial connective tissue graft in people with Gingival Recession, run by Cairo University.
Trial summary
The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession. 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?
- Acellular Dermal Matrix and Tunnel technique with the subepithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985).
- Subjects aged between 18 - 60 years old.
- Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome.
- Patients with good oral hygiene.
Who cannot join
- Current and former smokers.
- Pregnant females.
- Subjects received any periodontal therapy for minimum of 6 months prior to the study.
- Subjects taking drugs known to interfere with wound healing.
- Subjects with unacceptable oral hygiene with plaque index >2.
- Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.
About this study
Official title: Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions (Randomized Clinical Trial, Parallel Design)
The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.
Read the detailed description
Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.
- Conditions
- Gingival Recession
- Being tested
- Acellular Dermal Matrix, Tunnel technique with the subepithelial 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.
Acellular Dermal MatrixBiological
Also called Puros Dermis Allograft Tissue Matrix
Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.
Tunnel technique with the subepithelial connective tissue graftProcedure or surgery
Also called autogenous connective tissue graft
Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate
| Study group | Role | What they receive |
|---|---|---|
| Tunnel technique with acellular dermal matrix | Experimental | the tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface. Receives: Biological: Acellular Dermal Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft |
| subepithelial connective tissue graft | Active comparator | Tunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap. Receives: Biological: Acellular Dermal Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient Satisfaction .
measured by VAS scale
Measured: 1 year
Secondary outcomes (4)
root coverage
measured by periodontal probe
Measured: 1 year
Clinical Attachment Level
measured by periodontal probe
Measured: 1 year
Width of Keratinized Tissue
measured by periodontal probe
Measured: 1 year
Gingival Bio-type
measured by endodontics file
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatema Mohammed Ali Elmahdi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916186
- Sponsor's protocol ID
- CEBD-CU-2016-09-197
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions (Randomized Clinical Trial, Parallel Design)
- ClinicalTrials.gov ID
- NCT02916186
- Acronym / sponsor ID
- CEBD-CU-2016-09-197
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- 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 goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.
Detailed description
Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tunnel technique with acellular dermal matrix | Experimental | Biological: Acellular Dermal Matrix, Procedure: Tunnel technique with the subepithelial connective tissue graftthe tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface. |
| subepithelial connective tissue graft | Active comparator | Biological: Acellular Dermal Matrix, Procedure: Tunnel technique with the subepithelial connective tissue graftTunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985).
- Subjects aged between 18 - 60 years old.
- Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome.
- Patients with good oral hygiene.
Key exclusion criteria (6 listed)
- Current and former smokers.
- Pregnant females.
- Subjects received any periodontal therapy for minimum of 6 months prior to the study.
- Subjects taking drugs known to interfere with wound healing.
- Subjects with unacceptable oral hygiene with plaque index >2.
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 |
|---|---|---|
| Acellular Dermal MatrixAlso: Puros Dermis Allograft Tissue MatrixPuros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue. | Biological | Tunnel technique with acellular dermal matrix, subepithelial connective tissue graft |
| Tunnel technique with the subepithelial connective tissue graftAlso: autogenous connective tissue graftTunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate | Procedure or surgery | Tunnel technique with acellular dermal matrix, subepithelial connective tissue graft |
Primary outcome
patient Satisfaction .
Time frame: 1 year
measured by VAS scale
4 secondary outcomes
root coverage
Time frame: 1 year
Clinical Attachment Level
Time frame: 1 year
Width of Keratinized Tissue
Time frame: 1 year
Gingival Bio-type
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- 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 Acellular Dermal Matrix and Tunnel technique with the subepithelial 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 4 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 27 Sep 2016. 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?
patient Satisfaction . (time frame: 1 year). 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 27 Sep 2016.