Gingival RecessionPhase 4NCT00720707
Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage
A Phase 4 study testing CAF+ADM+EMD and CAF+ADM in people with Gingival Recession, run by Tabriz University at 1 site in Iran.
Trial summary
The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives . Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF+ADM+EMD and CAF+ADM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIran
- Study dates
- Apr 2006to Mar 2007
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having no systemic disease affecting the periodontium,
- No contraindication for elective surgery,
- Adequate oral hygiene ,
- No previous surgical attempts for root coverage at the studying sites,
- Vital teeth and signing a witness letter.
Who cannot join
- Smoking, presence of a restorations on tooth surface for test and control teeth,
- Pregnancy,
- Being under treatment with steroids,
- Peri-apical infection,
- Indication for antibiotic prophylaxis prior to dental treatments
Trial locations and contacts
1 site in 1 country.
Iran1 site
Faculty of Dentistry- Tabriz University of Medical Sciences
Tabriz, East Azerbaijan Province, 51664
About this study
Official title: Coronally Advanced Flap in Combination With Acellular Dermal Matrix With or Without Enamel Matrix Derivatives for Root Coverage
The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .
Read the detailed description
coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.
- Conditions
- Gingival Recession
- Being tested
- CAF+ADM+EMD, CAF+ADM
- Keywords
- Coronally advanced flap, gingival recession, enamel matrix protein, acellular dermal matrix, root coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF+ADM+EMDProcedure or surgery
Also called Alloderm®, Emdogain®
using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).
CAF+ADMProcedure or surgery
Also called Alloderm®, Emdogain®
using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.
| Study group | Role | What they receive |
|---|---|---|
| (CAF+ADM+EMD) | Experimental | using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD). Receives: Procedure: CAF+ADM+EMD |
| (CAF + ADM) | Active comparator | root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) Receives: Procedure: CAF+ADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of root coverage
Measured: at baseline, 2 and 6 months after treatment.
Secondary outcomes (1)
clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionFeb 2007
- Study completionMar 2007
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Reza Pourabbas, DDS, Principal investigator, Tabriz University (Medical Sciences)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720707
- Sponsor's protocol ID
- 841
- Status last verified
- Jul 2008
- First submitted
- 22 Jul 2008
- Last updated
- 23 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap in Combination With Acellular Dermal Matrix With or Without Enamel Matrix Derivatives for Root Coverage
- ClinicalTrials.gov ID
- NCT00720707
- Acronym / sponsor ID
- 841
- Conditions
- Gingival Recession
- Keywords
- Coronally advanced flap, gingival recession, enamel matrix protein, acellular dermal matrix, root coverage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Jul 2008 (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 aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .
Detailed description
coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (CAF+ADM+EMD) | Experimental | Procedure: CAF+ADM+EMDusing coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD). |
| (CAF + ADM) | Active comparator | Procedure: CAF+ADMroot coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having no systemic disease affecting the periodontium,
- No contraindication for elective surgery,
- Adequate oral hygiene ,
- No previous surgical attempts for root coverage at the studying sites,
- Vital teeth and signing a witness letter.
Key exclusion criteria (5 listed)
- Smoking, presence of a restorations on tooth surface for test and control teeth,
- Pregnancy,
- Being under treatment with steroids,
- Peri-apical infection,
- Indication for antibiotic prophylaxis prior to dental treatments
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 |
|---|---|---|
| CAF+ADM+EMDAlso: Alloderm®, Emdogain®using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD). | Procedure or surgery | (CAF+ADM+EMD) |
| CAF+ADMAlso: Alloderm®, Emdogain®using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures. | Procedure or surgery | (CAF + ADM) |
Primary outcome
the percentage of root coverage
Time frame: at baseline, 2 and 6 months after treatment.
1 secondary outcome
clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures
Time frame: 6 months after treatment
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 23 Jul 2008.
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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.
Reza Pourabbas, DDS principal investigator
Tabriz University (Medical Sciences)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CAF+ADM+EMD and CAF+ADM in people with Gingival Recession, run by Tabriz University at 1 site in Iran.
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 5 inclusion and 5 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 23 Jul 2008. 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 Iran. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the percentage of root coverage (time frame: at baseline, 2 and 6 months after treatment.). 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 23 Jul 2008.