Clinical trial NCT03631277: Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide
Official title: Clinical and Radiographic Evaluation of Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Keywords: Indirect pulp treatment
Photo-activated oral disinfection
Calcium Hydroxide
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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 .

Primary outcomes:
measure: postoperative pain: verbal rating scale
timeFrame: 2 months
measure: postoperative pain: verbal rating scale
timeFrame: 6 months
measure: postoperative pain: verbal rating scale
timeFrame: 9 months
measure: postoperative pain: verbal rating scale
timeFrame: 12 months
Secondary outcomes:
measure: Presence or absence of pain on percussion
timeFrame: 2,6,9 and 12 months
measure: Swelling
timeFrame: 2,6,9 and 12 months
measure: Sinus or fistula
timeFrame: 2,6,9 and 12 months
measure: Adverse radiographic findings
timeFrame: 2,6,9 and 12 months
measure: Thickness of newly formed dentin
timeFrame: 2,6,9 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ahmed M Abd Alsamad, PHD
role: STUDY_DIRECTOR
References: