Comparative Evaluation of Treatment Outcomes Of Indirect Pulp Capping Using Calcium Hydroxide, Bio-C Repair, And Calcimol-LC In Permanent Mandibular First Molars With Deep Carious Lesion: A Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Diksha kumari
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure.
Overview
Brief Summary
This clinical trial will be conducted in the Department of Conservative Dentistry and Endodontics, Himachal Dental College & Hospital, Sundernagar, Himachal Pradesh.
After obtaining informed consent from the patients (Annexure I attached), they will be randomly allocated into three groups:
Group A: Calcium Hydroxide
Group B: Bio-C Repair
Group C: Calcimol LC
For the purpose of the clinical trial, the pulpal response using Electric Pulp Test (EPT) and cold test will be recorded as a baseline reference.
If required (in cases of severe sensitivity during cavity preparation, rinsing, or in patients with dental phobia), the tooth will be anesthetized using 2% lignocaine containing 1:80,000 adrenaline. Isolation of the tooth will be achieved using a rubber dam.
A sterile diamond bur will be used in a high-speed handpiece under constant water spray. Carious tissue will be identified and removed with the aid of a caries detector dye. The dye will be applied to cavity walls to stain demineralized carious tissue, allowing precise identification of infected dentine.
Stained, demineralized tissue will be removed, starting from the peripheral walls toward the center of the lesion. Selective caries removal will be done carefully to reach relatively firm, non-stained dentine. This step will be guided by both visual and tactile feedback to avoid accidental pulp exposure.
Necrotic carious fragments will be removed with a spoon excavator, followed by a round bur in a low-speed handpiece with water cooling. A fresh sterile bur will be used in deeper areas of the lesion to reduce microbial contamination and prevent the introduction of infected dentine into the pulp.
The prepared cavity will be rinsed with normal saline to remove residual dye and then gently dried.
Pulp capping material (based on group allocation) will be applied to the cavity floor. This material will be covered by a layer of Glass Ionomer Cement (GIC).
Subsequently, the cavity will be restored with composite resin.
Pulpal response using EPT and cold test will be evaluated at 1 week, 3 months, and 6 months post-procedure for follow-up and clinical assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Day(s) to 40.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged between eighteen to forty years.
- •Presence of deep carious lesions without pulp exposure, with radiographic depth reaching three-fourths of the dentin.
- •Positive response to pulp sensibility tests, including Electric Pulp Test and cold test.
- •No history of spontaneous pain.
- •No evidence of periodontal ligament space widening.
- •Permanent molars with adequate coronal tooth structure suitable for restoration.
Exclusion Criteria
- •Presence of periapical pathology such as periapical radiolucency or root resorption.
- •Extensive loss of coronal tooth structure requiring prosthetic rehabilitation.
- •Presence of caries extending below the gingival margin.
- •History of chronic or recurrent pain associated with the affected tooth.
- •Presence of soft tissue swelling or sinus tract.
- •Teeth that have been previously treated endodontically or restored in the area under study.
- •Patients with known systemic health complications.
Outcomes
Primary Outcomes
Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure.
Time Frame: Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure.
Secondary Outcomes
- Clinical symptoms & comparative success rates(1st week 3 month & 6 month)
Investigators
Dr Diksha Kumari
Himachal Dental College and Hospital Sundernagar