- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654339
Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap (CCMMRCLDF)
Comparison of Conventional vs Microsurgical Method for Root Coverage by Lateral Displacement Flap
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study total, 30 patients were selected The patients initially received a comprehensive periodontal examination and complete plaque control program including oral hygiene to eliminate habits related to the aetiology of recession. Scaling, root planning and occlusal adjustments were done The patients were randomly assigned and divided into two groups. Group A and Group B. Patients with miller class II were treated with a laterally repositioned flap to obtain root coverage using conventional macrosurgical approach (15patients) and microsurgical approach(15patients)
The clinical parameters evaluated were height of gingival recession relative clinical attachment level which was measured as the distance from a fixed point in a stent to the bottom of the pocket and gingival biotype at baseline, 3 months and 6 months period
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Telangana
-
Hyderabad, Telangana, India, 500060
- Panineeya Mahavidyalaya Institute of Dental Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20-50 yrs
- ClassII gingival recession
- Vital teeth that were free from caries or inadequate restorations
- Sufficient width of attached gingiva
Exclusion Criteria:
- Any systemic diseases and smokers
- ClassI,III&IV gingival recession
- Abnormal frenal attachments
- Interdental bone loss with tooth mobility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
Group A-15 patients were allocated to the microsurgical group for root coverage. following scaling and root planning, the laterally repositioned flap was done using the microsurgical approach Group B-15 Patients were allocated to the conventional group for root coverage following scaling and root planning, the laterally repositioned flap was done using the macrosurgical approach |
Group A: After administration of local anaesthesia using ophthalmic microsurgical knives a V-shaped incision was made in the gingival recession area. the gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then secured with 6-0 absorbable sling suture without tension. the surgical procedure was done with seilar microscope 40X magnification. Group B: After administration of local anaesthesia using 15 no blade a V-shaped incision was made in the gingival recession area . gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then carefully secured with 4-0 absorbable sling suture |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vertical depth of recession
Time Frame: Change in level of gingival margin from baseline to 6 months.
|
The height of gingival recession: From cementoenamel junction to the free gingival margin.
|
Change in level of gingival margin from baseline to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
horizontal width of recession
Time Frame: Change in horizontal dimension of gingival margin from baseline to 6 months.
|
The width of gingival recession: Horizontal dimension of gingival defect at the level of Cementoenamel junction..
|
Change in horizontal dimension of gingival margin from baseline to 6 months.
|
Collaborators and Investigators
Investigators
- Study Director: veerendranath reddy, MDS, Panineeya Mahavidyalaya Institute of Dental Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kranthirecession
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gingival Recession, Localized
-
Centre Hospitalier Universitaire de LiegeRecruitingGingival Recession | Gingival Recession, LocalizedBelgium
-
Berceste GulerEnrolling by invitationGingival Recession | Gingival Recession, LocalizedTurkey
-
Ain Shams UniversityCompletedLocalized Gingival RecessionEgypt
-
Misr International UniversityAin Shams UniversityCompletedGingival Recession, LocalizedEgypt
-
Universidad de los Andes, ChileCompletedGingival Recession, LocalizedChile
-
Lauren M. F. SyrowikCompleted
-
Luis Alberto Chauca BajañaUniversidad de GuayaquilNot yet recruitingGingival Recession | Gingival Recession, Localized
-
Göteborg UniversityNot yet recruitingGingival Recession, Localized
-
Postgraduate Institute of Dental Sciences RohtakRecruitingGingival Recession, LocalizedIndia
-
Bezmialem Vakif UniversityCompletedGingival Recession, LocalizedTurkey
Clinical Trials on root coverage
-
Meenakshi Ammal Dental College and HospitalCompletedGingival Recession
-
Luis Alberto Chauca BajañaUniversidad de GuayaquilNot yet recruitingGingival Recession | Gingival Recession, Localized
-
University of Sao PauloCompletedStomatognathic Diseases | Periodontal Diseases | Mouth Diseases | Gingival Diseases | Gingival Recession | Periodontal AtrophyBrazil
-
University of Sao PauloGeistlich Pharma AGCompletedGingival Recession, GeneralizedBrazil
-
Okan UniversityCompletedPeriodontal Diseases | Gingival RecessionTurkey
-
Rio de Janeiro State UniversityCompleted
-
University of Sao PauloUnknown
-
Postgraduate Institute of Dental Sciences RohtakRecruiting
-
Medical University of WarsawUnknown
-
Case Western Reserve UniversityRecruitingRecession, GingivalUnited States