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

A

Al-Azhar University

Status

Completed

Conditions

Caries Arrested

Treatments

Procedure: partial caries removal

Study type

Interventional

Funder types

Other

Identifiers

NCT06585436
2/9/2022

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 6 patient groups

selective removal (chitosan loaded nano hydroxyapatite )
Experimental group
Description:
selective removal then apply chitosan loaded nano hydroxyapatite
Treatment:
Procedure: partial caries removal
selective removal (nano bioactive glass/GIC)
Experimental group
Description:
selective removal then apply (nano bioactive glass/GIC)
Treatment:
Procedure: partial caries removal
selective removal (nanosilver)
Experimental group
Description:
selective removal then apply (nanosilver)
Treatment:
Procedure: partial caries removal
stepwise removal (chitosan loaded nano hydroxyapatite )
Experimental group
Description:
stepwise removal then apply (chitosan loaded nano hydroxyapatite )
Treatment:
Procedure: partial caries removal
stepwise removal (nano bioactive glass/GIC)
Experimental group
Description:
selective removal (nano bioactive glass/GIC)
Treatment:
Procedure: partial caries removal
stepwise removal (nanosilver)
Experimental group
Description:
selective removal then apply (nanosilver)
Treatment:
Procedure: partial caries removal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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