Clinical Trials Directory

Trials / Completed

CompletedNCT03631277

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

Clinical and Radiographic Evaluation of Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEphoto-activated oral disinfectionApplication 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
DRUGCalcium Hydroxidecalcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration

Timeline

Start date
2015-01-01
Primary completion
2017-01-01
Completion
2017-04-01
First posted
2018-08-15
Last updated
2018-08-15

Source: ClinicalTrials.gov record NCT03631277. Inclusion in this directory is not an endorsement.