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Completed

NCT Number: NCT03631277

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

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.

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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

photo-activated oral disinfection

Device

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

Calcium hydroxide

Drug

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

Primary outcomes

  1. postoperative pain: verbal rating scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Presence or absence of pain on percussion

    Time frame: 2,6,9 and 12 months

    Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror

  2. Swelling

    Time frame: 2,6,9 and 12 months

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

  3. Sinus or fistula

    Time frame: 2,6,9 and 12 months

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

  4. Adverse radiographic findings

    Time frame: 2,6,9 and 12 months

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

  5. Thickness of newly formed dentin

    Time frame: 2,6,9 and 12 months

    using the Digora software. Unit of measurements were mm

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2018
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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