Clinical trial NCT03791255: Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
Official title: Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Deep Carious Lesion
Indirect Pulp Treatment
Keywords: resin modified calcium silicate
indirect pulp treatment
primary molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.

Detailed description: To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.

P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.

I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).

C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

Eligibility criteria: Inclusion Criteria:

1. Medically free children.
2. Age range from 4-7 years.
3. Presence of lower second primary molars with deep carious occlusal lesion.
4. No history of spontaneous pain (reversible pulpitis).
5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.

Exclusion Criteria:

1. Uncooperative children.
2. Any unmet previous criterion.

Primary outcomes:
measure: Postoperative pain
timeFrame: 1 month
measure: Postoperative pain
timeFrame: 3 months
measure: Postoperative pain
timeFrame: 6 months
measure: Postoperative pain
timeFrame: 12 months
Secondary outcomes:
measure: Swelling
timeFrame: 1 month
measure: Swelling
timeFrame: 3 months
measure: Swelling
timeFrame: 6 months
measure: Swelling
timeFrame: 12 months
measure: Sinus or fistula
timeFrame: 1 month
measure: Sinus or fistula
timeFrame: 3 months
measure: Sinus or fistula
timeFrame: 6 months
measure: Sinus or fistula
timeFrame: 12 months
measure: Tooth mobility
timeFrame: 1 month
measure: Tooth mobility
timeFrame: 3 months
measure: Tooth mobility
timeFrame: 6 months
measure: Tooth mobility
timeFrame: 12 months
measure: pain on percussion
timeFrame: 1 month
measure: pain on percussion
timeFrame: 3 months
measure: pain on percussion
timeFrame: 6 months
measure: pain on percussion
timeFrame: 12 months
measure: Occurrence of radiolucent lesions at furcation or periapical region
timeFrame: 1 months
measure: Occurrence of radiolucent lesions at furcation or periapical region
timeFrame: 3 months
measure: Occurrence of radiolucent lesions at furcation or periapical region
timeFrame: 6 months
measure: Occurrence of radiolucent lesions at furcation or periapical region
timeFrame: 12 months
measure: widening in the periodontal membrane space
timeFrame: 1 month
measure: widening in the periodontal membrane space
timeFrame: 3 months
measure: widening in the periodontal membrane space
timeFrame: 6 months
measure: widening in the periodontal membrane space
timeFrame: 12 months
measure: presence of internal or external root resorption
timeFrame: 1 month
measure: presence of internal or external root resorption
timeFrame: 3 months
measure: presence of internal or external root resorption
timeFrame: 6 months
measure: presence of internal or external root resorption
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: