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

"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"

To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.

Study Overview

• Status: Completed
• Conditions: Recession, Gingival
• Intervention / Treatment: Procedure: P-CTG; Procedure: CTG

Detailed Description

45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 509002
      • Svs Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main treatment group; soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG)	Procedure: P-CTG; soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG); Other Names: Experimental group
Active Comparator: Control group; soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)	Procedure: CTG; soft tissue closure of extraction sockets was done by connective tissue grafts (CTG); Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BL Gain	The displacement from the baseline to 6-months in BL dimensions was calculated and was described as BL gain.	Baseline to 6 months
Total displacement (TD)	The total displacement (TD) from the baseline to 6-months in MD dimensions was calculated and was described as TD gain.	Baseline to 6 months
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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences
• Investigators: Principal Investigator: Bhagyasree Medisetty, MDS, Svs Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: SVSIDS/PERIO/1/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No