search
Back to results

Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions

Primary Purpose

Recession, Gingival

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
P-CTG
CTG
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recession, Gingival

Eligibility Criteria

35 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al,

    1. Systemically healthy subjects within the age group of 20-50years
    2. with extraction defect type 2 and type 3 were included in this study

Exclusion Criteria:

  1. Medically compromised patients
  2. Subjects who underwent radiotherapy or chemotherapy and
  3. Smokers

Sites / Locations

  • SVS Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Main treatment group

Control group

Arm Description

soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG)

soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)

Outcomes

Primary Outcome Measures

BL Gain
The displacement from the baseline to 6-months in BL dimensions was calculated and was described as BL gain.
Total displacement (TD)
The total displacement (TD) from the baseline to 6-months in MD dimensions was calculated and was described as TD gain.
Angle of Displacement (AOD)
The Angle of Displacement (AOD)) from the baseline to 6-months in MD dimensions was calculated and was described as AOD Change.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2022
Last Updated
April 18, 2022
Sponsor
SVS Institute of Dental Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05342649
Brief Title
Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions
Official Title
"Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions- Results From Software-based Analysis of Clinical Data"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

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
To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.
Detailed Description
45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Main treatment group
Arm Type
Experimental
Arm Description
soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)
Intervention Type
Procedure
Intervention Name(s)
P-CTG
Other Intervention Name(s)
Experimental group
Intervention Description
soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG)
Intervention Type
Procedure
Intervention Name(s)
CTG
Other Intervention Name(s)
Control group
Intervention Description
soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)
Primary Outcome Measure Information:
Title
BL Gain
Description
The displacement from the baseline to 6-months in BL dimensions was calculated and was described as BL gain.
Time Frame
Baseline to 6 months
Title
Total displacement (TD)
Description
The total displacement (TD) from the baseline to 6-months in MD dimensions was calculated and was described as TD gain.
Time Frame
Baseline to 6 months
Title
Angle of Displacement (AOD)
Description
The Angle of Displacement (AOD)) from the baseline to 6-months in MD dimensions was calculated and was described as AOD Change.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al, Systemically healthy subjects within the age group of 20-50years with extraction defect type 2 and type 3 were included in this study Exclusion Criteria: Medically compromised patients Subjects who underwent radiotherapy or chemotherapy and Smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhagyasree Medisetty, MDS
Organizational Affiliation
SVS Institute of Dental Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
SVS Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions

We'll reach out to this number within 24 hrs