Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments

Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments: An in Vivo Study

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 Overview

• Status: Completed
• Conditions: Caries Arrested
• Intervention / Treatment: Procedure: partial caries removal

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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).
2. Teeth with a healthy response to the electrical pulp tester (DY 310, Denjoy Dental CO., LTD, China).
3. Teeth with the absence of spontaneous pain.
4. Teeth with a negative sensitivity to percussion.
5. Teeth with the absence of periapical lesions by a digital radiographic examination.
6. Clinically, all teeth were without any mobility.
7. Patients who will complete the procedure of follow up.
8. Patients who will sign the consent.

Exclusion Criteria:

1. Mutilated teeth or teeth with caries extending subgingivally.
2. Teeth with the existence of previous restorations.
3. Teeth with periodontal disease, any swelling, fistulas, signs of irreversible pulpitis or necrotic pulp.
4. Teeth with roots showing external or internal resorption.
5. Pregnant women.
6. Presence of any systemic disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: selective removal (chitosan loaded nano hydroxyapatite ); selective removal then apply chitosan loaded nano hydroxyapatite	Procedure: partial caries removal; removal of all cavity caries except last layer related to the pulp
Experimental: selective removal (nano bioactive glass/GIC); selective removal then apply (nano bioactive glass/GIC)	Procedure: partial caries removal; removal of all cavity caries except last layer related to the pulp
Experimental: selective removal (nanosilver); selective removal then apply (nanosilver)	Procedure: partial caries removal; removal of all cavity caries except last layer related to the pulp
Experimental: stepwise removal (chitosan loaded nano hydroxyapatite ); stepwise removal then apply (chitosan loaded nano hydroxyapatite )	Procedure: partial caries removal; removal of all cavity caries except last layer related to the pulp
Experimental: stepwise removal (nano bioactive glass/GIC); selective removal (nano bioactive glass/GIC)	Procedure: partial caries removal; removal of all cavity caries except last layer related to the pulp
Experimental: stepwise removal (nanosilver); selective removal then apply (nanosilver)	Procedure: partial caries removal; removal of all cavity caries except last layer related to the pulp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	evaluation of the post operative pain following restorations using modified USPHS	7 days
post operative pain	evaluation of the post operative pain following restorations using modified USPHS	3 months
post operative pain	evaluation of the post operative pain following restorations using modified USPHS	12 months
post operative pain	evaluation of the post operative pain following restorations using modified USPHS	18 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 2/9/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No