Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion

NCT03693066 | Completed DMC

• 1 other identifier: 213S004
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to evaluate the clinical and microbiological effectiveness of the ozone application in two-visit indirect pulp therapy. Materials and Methods: One hundred and five lower first molar teeth with deep caries lesion were included and randomly assigned three groups to apply two-visit indirect pulp therapy. Treatment procedure was applied without any disinfectant(control), with 60s 2% chlorhexidine digluconate(CHX) or 60s ozone application. In four different stage (after initial excavation, ozone/CHX application before the temporary restoration, four months later immediately after removing temporary restoration, and final excavation) dentin humidity, consistency and colour properties were recorded to evaluate the clinical characteristics of the tissue, and standard dentin samples were collected for the microbiological analysis of mutans streptococci, lactobacilli and the total number of colony forming units. The data were analyzed by using Mann-Whitney-U test for multiple comparisons.

Conditions

Ozone; Caries

Keywords

stepwise excavation; indirect pulp capping; ozone; deep caries

Outcome Measures

Primary Outcomes (1)

• Changes microbiological count: from baseline to 4 months

  mutans streptococci, lactobacilli and the total number of colony forming units were counted.

  Baseline and Four months later

Secondary Outcomes (3)

• Changes characteristics of the dentin humidity: from baseline to 4 months

  Baseline and Four months later

• Changes characteristics of the dentin consistency: from baseline to 4 months

  Baseline and Four months later

• Changes characteristics of the dentin color: from baseline to 4 months

  Baseline and Four months later

Study Arms (3)

ozone

EXPERIMENTAL

Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with ozone. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The cavity was exposed to gaseous ozone for 60 seconds, with an ozone delivery system. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement to reopen 4 months later.

Other: Ozone

chlorhexidine digluconate

ACTIVE COMPARATOR

Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with chlorhexidine digluconate. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. Following the excavation, 2% chlorhexidine digluconate was applied to the cavity for 60 seconds using a brush. According to the manufacturer instructions, puddled solution was removed with a new brush without dry to leave site moist. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.

Other: chlorhexidine digluconate

Control

ACTIVE COMPARATOR

Thirty five molar teeth with deep caries lesion were selected to apply conventional two-visit indirect pulp therapy (control). The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.

Other: Control

Interventions

Ozone OTHER

In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as ozone.

ozone

chlorhexidine digluconate OTHER

In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as chlorhexidine digluconate.

chlorhexidine digluconate

Control OTHER

Also known as: without any cavity disinfectant

Control

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Without signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.)
• The absence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination;
• Presence of normal lamina dura and periodontal range, absence of lesion, internal or external resorption or calcification in or around the root in the radiological examination.

You may not qualify if:

• Children with special health care needs
• Children with dental crowding limiting the child's ability to maintain oral hygiene
• Teeth with clinical and/ or radiological signs or symptoms of non- vitality
• Teeth with clinical and radiological signs or symptoms of irreversible pulpitis, or dental abscess (Pain, mobility, tenderness to percussion, draining sinus, pulp polyp, furcal or periapical radiolucency, root resorption)

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

MeSH Terms

Interventions

Ozone; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• Merve Akcay, assoc prof

  Izmir Katip Celebi Uni

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof dr

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09