NCT03654339

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 20, 2018

Last Update Submit

August 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • vertical depth of recession

    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 Outcomes (1)

  • horizontal width of recession

    Change in horizontal dimension of gingival margin from baseline to 6 months.

Study Arms (1)

experimental group

EXPERIMENTAL

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

Procedure: root coverage

Interventions

root coveragePROCEDURE

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

experimental group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-50 yrs
  • ClassII gingival recession
  • Vital teeth that were free from caries or inadequate restorations
  • Sufficient width of attached gingiva

You may not qualify if:

  • Any systemic diseases and smokers
  • ClassI,III\&IV gingival recession
  • Abnormal frenal attachments
  • Interdental bone loss with tooth mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panineeya Mahavidyalaya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • veerendranath reddy, MDS

    panineeya mahavidyalaya institute of dental sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PG Student

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 31, 2018

Study Start

August 24, 2017

Primary Completion

March 31, 2018

Study Completion

August 16, 2018

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations