Gingival RecessionNCT03053921
Placental Membrane for Root Coverage
A study testing recession coverage and recession coverage and membrane in people with Gingival Recession, run by Meenakshi Ammal Dental College and Hospital.
Trial summary
Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally advanced flap in covering single and multiple Miller's class I and II gingival recession defects. Read more about this study
- Who is it for?
- Ages 23 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- recession coverage and recession coverage and membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2015to 15 Jun 2016
- 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 23 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients within the age group 23 to 55 years
- Bilateral, upper or lower, Miller's class I and Class II gingival recession defects confined to the anterior and premolar region.
- Presence of identifiable cemento-enamel junction
- Presence of keratinized tissue apical to the exposed root
Who cannot join
- Systemic complications
- Occlusal interferences
- Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing
- Previous periodontal surgery on the involved site
- Smokers
- Pregnant and lactating mothers
About this study
Official title: Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane
Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally advanced flap in covering single and multiple Miller's class I and II gingival recession defects.
Read the detailed description
STUDY DESIGN A total number of 60 teeth in 15 subjects were selected. Patients with bilateral Miller's class I and II gingival recession defects in the maxillary or mandibular anterior and premolar region were selected and divided into two groups using a split mouth design.
GroupI (Control) -30 recession defects treated with coronally advanced flap alone, using Zucchelli's technique.
Group II (Test) - 30 recession defects treated with coronally advanced flap, using Zucchelli's technique along with placental membrane.
.
CLINICAL PARAMETERS:
- Probing Pocket Depth(PPD)
- Clinical Attachment Level(CAL)
- Height of Gingival Recession(HGR)
- Width of Gingival Recession(WGR)
- Width of Keratinized Gingiva(WKG) The clinical parameters were assessed \& recorded on 0 day, 90th day and 180th day
- Conditions
- Gingival Recession
- Being tested
- recession coverage, recession coverage and membrane
- Keywords
- gingival recession, Zuchellis technique,, placental membrane
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recession coverageProcedure or surgery
Also called root coverage technique
recession coverage done using Zuchellis technique
recession coverage and membraneProcedure or surgery
Also called root coverage technique with membrane
recession coverage done using Zuchellis technique with placental membrane
| Study group | Role | What they receive |
|---|---|---|
| recession coverage | Placebo comparator | 30 recession defects treated with Zucchelli's technique. Receives: Procedure: recession coverage |
| recession coverage and membrane | Active comparator | 30 recession defects treated with Zucchelli's technique along with placental membrane. Receives: Procedure: recession coverage and membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of Gingival recession
The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe
Measured: 6 months
Secondary outcomes (2)
Clinical attachment level
Clinical attachment level is measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket using williams periodontal probe
Measured: Baseline and 6 months
Width of Keratinized Gingiva
It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start19 Aug 2015
- Primary completion23 Mar 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
- Investigators
- Sarah George, BDS, Principal investigator, Meenakshi Ammal Dental College and Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053921
- Sponsor's protocol ID
- MADC/IRB/2015/94
- Status last verified
- Jan 2017
- First submitted
- 6 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
PubMed 19563288Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015/12971.6572. Epub 2015 Sep 1.
PubMed 26501023
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane
- ClinicalTrials.gov ID
- NCT03053921
- Acronym / sponsor ID
- MADC/IRB/2015/94
- Conditions
- Gingival Recession
- Keywords
- gingival recession, Zuchellis technique,, placental membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- 23 Mar 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 15 Feb 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.
Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally advanced flap in covering single and multiple Miller's class I and II gingival recession defects.
Detailed description
STUDY DESIGN A total number of 60 teeth in 15 subjects were selected. Patients with bilateral Miller's class I and II gingival recession defects in the maxillary or mandibular anterior and premolar region were selected and divided into two groups using a split mouth design.
GroupI (Control) -30 recession defects treated with coronally advanced flap alone, using Zucchelli's technique.
Group II (Test) - 30 recession defects treated with coronally advanced flap, using Zucchelli's technique along with placental membrane.
.
CLINICAL PARAMETERS:
- Probing Pocket Depth(PPD)
- Clinical Attachment Level(CAL)
- Height of Gingival Recession(HGR)
- Width of Gingival Recession(WGR)
- Width of Keratinized Gingiva(WKG) The clinical parameters were assessed \& recorded on 0 day, 90th day and 180th day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recession coverage | Placebo comparator | Procedure: recession coverage30 recession defects treated with Zucchelli's technique. |
| recession coverage and membrane | Active comparator | Procedure: recession coverage and membrane30 recession defects treated with Zucchelli's technique along with placental membrane. |
Who may qualify
- Ages
- 23 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients within the age group 23 to 55 years
- Bilateral, upper or lower, Miller's class I and Class II gingival recession defects confined to the anterior and premolar region.
- Presence of identifiable cemento-enamel junction
- Presence of keratinized tissue apical to the exposed root
Key exclusion criteria (6 listed)
- Systemic complications
- Occlusal interferences
- Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing
- Previous periodontal surgery on the involved site
- Smokers
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 |
|---|---|---|
| recession coverageAlso: root coverage techniquerecession coverage done using Zuchellis technique | Procedure or surgery | recession coverage |
| recession coverage and membraneAlso: root coverage technique with membranerecession coverage done using Zuchellis technique with placental membrane | Procedure or surgery | recession coverage and membrane |
Primary outcome
Height of Gingival recession
Time frame: 6 months
The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe
2 secondary outcomes
Clinical attachment level
Time frame: Baseline and 6 months
Width of Keratinized Gingiva
Time frame: Baseline and 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 15 Feb 2017.
- Background: PubMed 19563288Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
- Background: PubMed 26501023Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015/12971.6572. Epub 2015 Sep 1.
- Individual participant dataSharing planned: No
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Gingival Recession
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.
Sarah George, BDS principal investigator
Meenakshi Ammal Dental College and Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing recession coverage and recession coverage and membrane in people with Gingival Recession, run by Meenakshi Ammal Dental College and Hospital.
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: finished, as of the sponsor's last update on 15 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Height of Gingival recession (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 NCT03053921, which also lists 2 linked publications.
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 Feb 2017.