Gingival Recession, GeneralizedCAF and SVITNCT03037320
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial
A study testing comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth in people with Gingival Recession, Generalized and Root Coverage, run by Indira Gandhi Institute of Dental Science at 1 site in India.
Trial summary
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Gingival Recession, Generalized, Root Coverage
- What is being tested?
- comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to 30 Dec 2018
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females subjects of 20-50 years.
- Patients with multiple gingival recession (2-4 teeth) of class I \& II in maxillary teeth.
- Patients with well aligned teeth
Who cannot join
- Patients with class III \&IV gingival recession in maxillary teeth
- Recession in relation to molars
- Patients with systemic diseases
- Medically compromised patients
- Patient with history of smoking
- Patients with erosion and root caries
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Indira Gandhi Institute of dental sciences
Puducherry, Puducherry, 607402
Hema pichandi, BDS, 9442804426 ext. +91, drhema6119@gamil.com
Pratebha Balu, MDS, 9894360543 ext. +91, pratebhabalu@igids.ac.in
About this study
Official title: Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.
Read the detailed description
the subjects attending the OPD department of periodontology, IGIDS and patients will be selected based on inclusion criteria, informed consent to be obtained from the patients,
Randomization process:
- Patient to be selected for one of the two procedures by simple random sampling (Lottery method)
- Baseline value will be recorded by a calibrated examiner other than the operator
- The procedure is performed by the operator ( primary investigator)
- Post op values to be recorded by the calibrated examiner.
Patient to be reviewed at 3 and 6 months Results will be dicussed
- Conditions
- Gingival Recession, Generalized, Root Coverage
- Being tested
- comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teethProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | root coverage to be performed by semilunar vestibular incision technique Receives: Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth |
| group B | Other | root coverage by coronally advanced flap Receives: Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of root coverage
root coverage in millimeters
Measured: 6 months
Secondary outcomes (1)
width of keratinised gingiva
increase of width measured in millimeters
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 posted31 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, GeneralizedStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira Gandhi Institute of Dental Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Hema.P, Indira Gandhi Institute of Dental Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037320
- Sponsor's protocol ID
- IGIDSIEC2016NDP28PGHPPAI
- Acronym
- CAF and SVIT
- Status last verified
- Jan 2017
- First submitted
- 27 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled
- ClinicalTrials.gov ID
- NCT03037320
- Acronym / sponsor ID
- CAF and SVIT / IGIDSIEC2016NDP28PGHPPAI
- Conditions
- Gingival Recession, Generalized, Root Coverage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Indira Gandhi Institute of Dental ScienceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 31 Jan 2017 (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.
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.
Detailed description
the subjects attending the OPD department of periodontology, IGIDS and patients will be selected based on inclusion criteria, informed consent to be obtained from the patients,
Randomization process:
- Patient to be selected for one of the two procedures by simple random sampling (Lottery method)
- Baseline value will be recorded by a calibrated examiner other than the operator
- The procedure is performed by the operator ( primary investigator)
- Post op values to be recorded by the calibrated examiner.
Patient to be reviewed at 3 and 6 months Results will be dicussed
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 |
|---|---|---|
| group A | Experimental | Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teethroot coverage to be performed by semilunar vestibular incision technique |
| group B | Other | Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teethroot coverage by coronally advanced flap |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females subjects of 20-50 years.
- Patients with multiple gingival recession (2-4 teeth) of class I \& II in maxillary teeth.
- Patients with well aligned teeth
Key exclusion criteria (6 listed)
- Patients with class III \&IV gingival recession in maxillary teeth
- Recession in relation to molars
- Patients with systemic diseases
- Medically compromised patients
- Patient with history of smoking
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 |
|---|---|---|
| comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth | Procedure or surgery | group A, group B |
Primary outcome
amount of root coverage
Time frame: 6 months
root coverage in millimeters
1 secondary outcome
width of keratinised gingiva
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth in people with Gingival Recession, Generalized and Root Coverage, run by Indira Gandhi Institute of Dental Science at 1 site in India.
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: status not confirmed, as of the sponsor's last update on 1 Feb 2017. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hema pichandi, BDS (9442804426 ext. +91, drhema6119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of root coverage (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 1 Feb 2017.