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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03631277
Collaborator
(none)
32
2
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: photo-activated oral disinfection
  • Drug: Calcium Hydroxide
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Device: 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
Other Names:
  • PAD
  • Active Comparator: 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

    Drug: 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
    Other Names:
  • Ca(OH)2
  • Outcome Measures

    Primary Outcome Measures

    1. postoperative pain: verbal rating scale [2 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

    2. postoperative pain: verbal rating scale [6 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

    3. postoperative pain: verbal rating scale [9 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

    4. 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

    1. 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

    2. Swelling [2,6,9 and 12 months]

      Binary outcome (Present or absent). Assessed by visual examination by the examiner

    3. Sinus or fistula [2,6,9 and 12 months]

      Binary outcome (Present or absent). Assessed by visual examination by the examiner

    4. Adverse radiographic findings [2,6,9 and 12 months]

      Binary outcome (Present or absent). Assessed by Digora software

    5. Thickness of newly formed dentin [2,6,9 and 12 months]

      using the Digora software. Unit of measurements were mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts 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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Ahmed M Abd Alsamad, PHD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    marwa aly fouad elchaghaby, Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt., Cairo University
    ClinicalTrials.gov Identifier:
    NCT03631277
    Other Study ID Numbers:
    • pulp capping
    First Posted:
    Aug 15, 2018
    Last Update Posted:
    Aug 15, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by marwa aly fouad elchaghaby, Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt., Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2018