NCT05342649

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

April 8, 2022

Last Update Submit

April 18, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Main treatment group

EXPERIMENTAL

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

Procedure: P-CTG

Control group

ACTIVE COMPARATOR

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

Procedure: CTG

Interventions

P-CTGPROCEDURE

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

Also known as: Experimental group
Main treatment group
CTGPROCEDURE

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

Also known as: Control group
Control group

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Medically compromised patients
  • Subjects who underwent radiotherapy or chemotherapy and
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SVS Institute of Dental Sciences

Hyderabad, Telangana, 509002, India

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Bhagyasree Medisetty, MDS

    SVS Institute of Dental Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 22, 2022

Study Start

January 1, 2018

Primary Completion

May 1, 2019

Study Completion

June 20, 2019

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations