Effects of Total and Selective Caries Removal - Requiring or Avoiding Vital Pulp Therapy - on Pulp Vitality and Postoperative Pain in Deep Carious Mature Permanent Teeth: A Split-Mouth Clinical Study
1 other identifier
interventional
15
1 country
1
Brief Summary
The effect of selective caries cleaning and total caries cleaning on pulp health and post operative pain in teeth with deep caries will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
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
First Submitted
Initial submission to the registry
June 19, 2025
CompletedFirst Posted
Study publicly available on registry
June 27, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedMarch 30, 2026
March 1, 2026
7 months
June 19, 2025
March 27, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Early postoperative pain intensity (VAS) after total vs. selective excavation
The patient will be asked to rate his/her pain on day 1, 3 and 7 according to VAS
first week
dentin bridge formation
no dentin bridge formation is expected in selective caries cleaning, while dentin bridge formation will be observed radiologically in total cleaning
twelve months
pulp survival at twelve months
The pulp is expected to remain vital, with no percussion tenderness and no spontaneous pain
twelve months
Study Arms (2)
Arm 1
ACTIVE COMPARATORComplete caries excavation
Arm 2
EXPERIMENTALPartial caries excavation
Interventions
Arm 1: "Total caries removal (complete excavation to hard dentin)"
Eligibility Criteria
You may qualify if:
- Patients aged ≥15 years with bilateral deep carious mature permanent teeth.
- Positive vitality test (cold sensitivity).
- No spontaneous pain or periapical radiolucency.
- Willingness to attend 6- and 12-month follow-ups
You may not qualify if:
- Uncontrolled systemic diseases Pregnancy or allergy to dental materials used Teeth with irreversible pulpitis (spontaneous pain, necrosis) Non-restorable teeth (fractures, extensive decay)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Patients and outcome assessors were blinded to the intervention groups. The operator was not blinded due to the visible differences between total and selective caries removal techniques.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2025
First Posted
June 27, 2025
Study Start
July 1, 2025
Primary Completion
February 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03