Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions
Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study
1 other identifier
interventional
146
1 country
1
Brief Summary
The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
1 active site
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
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedMay 5, 2020
May 1, 2020
1.3 years
April 24, 2020
May 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical success
Clinical success will be judged by following criteria * Positive response on vitality test. * Absence of pain on percussion and any other signs and/or symptoms of irreversible pulpitis and pulp necrosis Criteria for failure will be * Negative response on pulp vitality test. * Tenderness to percussion and teeth exhibiting any clinical signs and/or symptoms of irreversible pulpitis and pulp necrosis.
Baseline to 12 months
Secondary Outcomes (1)
Radiographic Success
Baseline to 12 months
Study Arms (2)
Selective caries removal to soft dentin (one step)
ACTIVE COMPARATORIn selective caries removal to soft dentine, after caries excavation application of liner will be done on pulpal floor. Teeth will then be filled with composite resin material.
Stepwise caries removal (two step)
ACTIVE COMPARATORThe stepwise caries removal is a two step procedure. The first step is similar to selective caries removal to soft dentin group. In the second step, after 6 months lesion will be re-entered to remove remaining carious tissue till firm dentin is encountered. Once all the caries is removed from floor of cavity a liner followed by final restoration with composite will be performed.
Interventions
After caries removal restoration of tooth will be performed
After caries removal restoration of tooth will be performed
Eligibility Criteria
You may qualify if:
- Outpatient in age range of 18yr-60yr
- Permanent mandibular posterior teeth with deep caries
- Caries extending to \>3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph
- Positive response to cold test and electric pulp test
You may not qualify if:
- Any general disease affecting the caries e.g. patient under head and neck radiotherapy
- Patients with immuno-compromised status
- Tooth with fracture line, cracks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Science
Rohtak, Haryana, 124001, India
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
- SPONSOR
Study Record Dates
First Submitted
April 24, 2020
First Posted
May 5, 2020
Study Start
January 1, 2020
Primary Completion
April 30, 2021
Study Completion
June 15, 2021
Last Updated
May 5, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share