Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap (CCMMRCLDF)
Primary Purpose
Gingival Recession, Localized
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
root coverage
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Localized
Eligibility Criteria
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
Sites / Locations
- Panineeya Mahavidyalaya Institute of Dental Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
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
Outcomes
Primary Outcome Measures
vertical depth of recession
The height of gingival recession: From cementoenamel junction to the free gingival margin.
Secondary Outcome Measures
horizontal width of recession
The width of gingival recession: Horizontal dimension of gingival defect at the level of Cementoenamel junction..
Full Information
NCT ID
NCT03654339
First Posted
August 20, 2018
Last Updated
August 30, 2018
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT03654339
Brief Title
Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap
Acronym
CCMMRCLDF
Official Title
Comparison of Conventional vs Microsurgical Method for Root Coverage by Lateral Displacement Flap
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
August 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was conducted to assess the evaluation of micro and Macro surgical approach in the treatment of grade II gingival recessions using the laterally repositioned flap
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Localized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The patients will be equally divided into two test groups. Group A and Group B after phase I therapy. the group A patients will be treated with laterally repositioned flap to obtain root coverage using microsurgical approach. The group B patients will be treated with laterally repositioned flap to obtain root coverage using macrosurgical approach
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
root coverage
Intervention Description
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
Primary Outcome Measure Information:
Title
vertical depth of recession
Description
The height of gingival recession: From cementoenamel junction to the free gingival margin.
Time Frame
Change in level of gingival margin from baseline to 6 months.
Secondary Outcome Measure Information:
Title
horizontal width of recession
Description
The width of gingival recession: Horizontal dimension of gingival defect at the level of Cementoenamel junction..
Time Frame
Change in horizontal dimension of gingival margin from baseline to 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
veerendranath reddy, MDS
Organizational Affiliation
panineeya mahavidyalaya institute of dental sciences
Official's Role
Study Director
Facility Information:
Facility Name
Panineeya Mahavidyalaya Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25393983
Citation
Nizam N, Bengisu O, Sonmez S. Micro- and macrosurgical techniques in the coverage of gingival recession using connective tissue graft: 2 years follow-up. J Esthet Restor Dent. 2015 Mar-Apr;27(2):71-83. doi: 10.1111/jerd.12124. Epub 2014 Nov 13.
Results Reference
result
Learn more about this trial
Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap
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