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Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries

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ClinicalTrials.gov Identifier: NCT02918903
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nouran Mamdouh Ahmed, Cairo University

Brief Summary:
The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.

Condition or disease Intervention/treatment Phase
Deep Caries Procedure: Minimal caries removal Procedure: Complete caries removal Not Applicable

Detailed Description:
Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Minimal caries removal
the patients in this group will be treated by minimal caries removal technique, where only caries at lateral walls of cavity is removed, stainless steel crown preparation is performed and then stainless steel crown is placed as final restoration.
Procedure: Minimal caries removal
the experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration.

Active Comparator: Complete caries removal
patients in this group will be treated by complete caries removal technique, where all caries will be removed, a base of resin modified glass ionomer is placed and then stainless steel crown is placed as final restoration.
Procedure: Complete caries removal
the control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration.




Primary Outcome Measures :
  1. Post operative pain assessed by direct questioning as binary outcome [ Time Frame: 9 months ]
    Assessed by direct questioning pain history


Secondary Outcome Measures :
  1. incidence of pulp exposure [ Time Frame: Within 30 minutes ]
    The outcome will be measured during the treatment visit which is estimated to be 30 minutes

  2. radio-graphic success [ Time Frame: 9 months ]
    No external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary molar with deep dentin caries involving occlusal &/or occluso-proximal surfaces.
  • Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
  • Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
  • Absence of abnormal tooth mobility.
  • Absence of pain on percussion.
  • Restorable tooth.

Radiographic inclusion criteria:

  • Extension of dental caries one-third or more of the entire dentin thickness.
  • No super- imposition of dental caries on the dental pulp.
  • No widened periodontal ligament (PDL) space.
  • No radiolucency in the peri-apical or furcation areas.
  • No pathologic internal or external root resorption.
  • No pulp canal calcification or obliteration.

Exclusion Criteria:

  1. Patients experience any signs or symptoms of pulpal or peri-apical pathology.
  2. Patients with systemic diseases requiring special dental consideration.
  3. Unmotivated, uncooperative patients.
  4. Patients unable to attend follow-up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918903


Contacts
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Contact: Nouran M Abdelgawad 00201275653365 nouran1186@hotmail.com
Contact: Norhan El-dokky, PhD 00201111223249

Locations
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Egypt
Faculty of denntistry Recruiting
Cairo, El-manyal, Egypt, 11553
Contact: Norhan Eldokky, PhD    0020111223249      
Contact: Dalia Moheb, PhD    002005556534      
Sponsors and Collaborators
Cairo University

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Responsible Party: Nouran Mamdouh Ahmed, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02918903     History of Changes
Other Study ID Numbers: CEBD-CU-2016-09-206
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No