Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments: An in Vivo Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- post operative pain
Study Overview
Brief Summary
The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with first and second molars with occlusal deep carious lesions (Class I) extending to the inner third of dentin thickness on radiographic examination using (i-sensor H1, Woodpecker, China).
- •Teeth with a healthy response to the electrical pulp tester (DY 310, Denjoy Dental CO., LTD, China).
- •Teeth with the absence of spontaneous pain.
- •Teeth with a negative sensitivity to percussion.
- •Teeth with the absence of periapical lesions by a digital radiographic examination.
- •Clinically, all teeth were without any mobility.
- •Patients who will complete the procedure of follow up.
- •Patients who will sign the consent.
Exclusion Criteria
- •Mutilated teeth or teeth with caries extending subgingivally.
- •Teeth with the existence of previous restorations.
- •Teeth with periodontal disease, any swelling, fistulas, signs of irreversible pulpitis or necrotic pulp.
- •Teeth with roots showing external or internal resorption.
- •Pregnant women.
- •Presence of any systemic disease.
Outcomes
Primary Outcomes
post operative pain
Time Frame: 18 months
evaluation of the post operative pain following restorations using modified USPHS
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Ahmed Abdallah Rabiea
teaching assistant
Al-Azhar University
