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Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars

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ClinicalTrials.gov Identifier: NCT03119779
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Passant Nagy, Cairo University

Brief Summary:

Objective:

To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.

Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.


Condition or disease Intervention/treatment Phase
Caries, Dental Drug: MTA-Anglus Drug: TheraCal Not Applicable

Detailed Description:
Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Pulpotomy (Partial or Complete) Using Resin-Modified Calcium Silicate Versus MTA-Anglus on Survival Rate of Cariously-Exposed Vital Young Permanent Molars:A Randomized Clinical Trial
Actual Study Start Date : September 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Arm Intervention/treatment
Experimental: TheraCal vital pulp therapy
Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.
Drug: TheraCal
TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.
Other Name: TheraCal vital pulp therapy

Active Comparator: MTA vital pulp therapy
Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.
Drug: MTA-Anglus
MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.
Other Name: MTA-Anglus vital pulp therapy




Primary Outcome Measures :
  1. Survival rate [ Time Frame: 12 months ]
    absence of any complication or complementary treatment (absence of spontaneous pain or swelling)


Secondary Outcome Measures :
  1. periapical radiolucency [ Time Frame: 12 months ]
    presence or absence of periapical radiolucency radiographically

  2. internal/ external root resorption [ Time Frame: 12 months ]
    presence or absence of internal/ external root resorption radiographically

  3. Root maturation [ Time Frame: 12 months ]
    Root maturation assessment radiographically


Other Outcome Measures:
  1. Time lapse till final restoration performed [ Time Frame: from 5 till 20 minutes ]
    measured using stop watch to assess which material needs less chair side time to be finished.



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Restorable permanent molars with deep caries and pain could be relieved with analgesics

Exclusion Criteria:

  • criteria of exclusion of teeth were:

    • pathological mobility, swelling or tenderness to percussion/palpation;
    • pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space;
    • at the operative procedure, hemorrhage control is unachievable

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): NCT03119779


Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Passant Nagi, MSc Assisternt lecturer
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Responsible Party: Passant Nagy, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03119779    
Other Study ID Numbers: CEBD-CU-2014-09-15
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Passant Nagy, Cairo University:
pulpotomy
deep caries
permanent molars
MTA
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases