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

Not Applicable

Completed

• Conditions: Deep Caries
• Interventions: Device: photo-activated oral disinfection; Drug: Calcium Hydroxide

• Registration Number: NCT03631277
• Lead Sponsor: Cairo University

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 .

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2017-01
• Study Completion: 2017-04
• Status Verified: 2018-08
• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

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Exclusion Criteria

• Previously restored teeth .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
photo-activated oral disinfection	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
calcium hydroxide	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

Primary Outcome Measures

Name	Time	Method
postoperative pain: verbal rating scale	12 months	categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Presence or absence of pain on percussion	2,6,9 and 12 months	Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
Swelling	2,6,9 and 12 months	Binary outcome (Present or absent). Assessed by visual examination by the examiner
Sinus or fistula	2,6,9 and 12 months	Binary outcome (Present or absent). Assessed by visual examination by the examiner
Adverse radiographic findings	2,6,9 and 12 months	Binary outcome (Present or absent). Assessed by Digora software
Thickness of newly formed dentin	2,6,9 and 12 months	using the Digora software. Unit of measurements were mm