Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide

NCT ID: NCT03631277

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-04-30

Brief Summary

This study aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars.

Detailed Description

Indirect pulp treatment is a procedure in which pulp exposure is prevented by preserving the carious dentin bordering the pulp and sealing the pulp with a biocompatible material. . Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect. However, several disadvantages were reported with its use over time including poor seal, lack of chemical and mechanical adhesion, poor strength, long-term solubility, enhanced degradation after acid etching and tunnel defects in the dentin bridge . The operative tradition is to remove softened dentin to eliminate infected tissue; however, it is impossible to eradicate all the micro-organisms because few will persist although all soft dentin was excavated.

Evidence suggest that for arresting caries lesions, it is not crucial to completely remove the infected dentin and that selective caries removal and composite restoration can yield better clinical results . For more conservative and effective treatment, disinfection instead of complete caries removal has been encouraged. . PAD is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens . The usage of PAD in caries management can eradicate residual bacteria in soft dentin, reassures rapid healing and improve the prognosis of treatment .

Conditions

Deep Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

photo-activated oral disinfection

photo-activated oral disinfection is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens

Group Type: EXPERIMENTAL

photo-activated oral disinfection

Intervention Type: DEVICE

Application of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration

calcium hydroxide

Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type: DRUG

calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration

Interventions

photo-activated oral disinfection

Application of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration

Intervention Type: DEVICE

Calcium Hydroxide

calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration

Intervention Type: DRUG

Other Intervention Names

PAD; Ca(OH)2

Eligibility Criteria

Inclusion Criteria

• Restorable lower first permanent molars with deep carious lesions
• Absence of clinical signs and symptoms of irreversible pulpitis, fistula, swelling in periodontal tissues or abnormal tooth mobility
• Absence of adverse radiographic findings
• Compliant patient/parent and (e) Absence of any systemic disease.

Exclusion Criteria

• Previously restored teeth .

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

marwa aly fouad elchaghaby

Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Abd Alsamad, PHD

Role: STUDY_DIRECTOR

Cairo University

Other Identifiers

pulp capping

Identifier Type: -

Identifier Source: org_study_id