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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03631277
Enrollment
32
Registered
2018-08-15
Start date
2015-01-31
Completion date
2017-04-30
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Caries

Keywords

Indirect pulp treatment, Photo-activated oral disinfection, Calcium Hydroxide

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 .

Interventions

DEVICEphoto-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

DRUGCalcium Hydroxide

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain: verbal rating scale2 monthscategorical (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

MeasureTime frameDescription
Presence or absence of pain on percussion2,6,9 and 12 monthsBinary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
Swelling2,6,9 and 12 monthsBinary outcome (Present or absent). Assessed by visual examination by the examiner
Sinus or fistula2,6,9 and 12 monthsBinary outcome (Present or absent). Assessed by visual examination by the examiner
Adverse radiographic findings2,6,9 and 12 monthsBinary outcome (Present or absent). Assessed by Digora software
Thickness of newly formed dentin2,6,9 and 12 monthsusing the Digora software. Unit of measurements were mm

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026