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Assessment of a New Protocol for Indirect Pulp Capping Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03071588
Recruitment Status : Unknown
Verified March 2018 by King's College London.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
King's College London

Brief Summary:
The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. It was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.

Condition or disease Intervention/treatment Phase
Reversible Pulpitis Device: Mechanical rotary burs Device: Carisolv gel Not Applicable

Detailed Description:

Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. One group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal, the other group will be treated with a more conservative clinical procedure using CarisolvTM gel with the aid of an operating microscope for caries removal. The study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. The study also compare the radiographical findings of 3D cone beam computed tomography (CBCT) scans with that of normal Xrays in detecting the presence of early bone changes associated with the roots of these teeth.

The study carried out at King's College London/ Dental Institute at Guy's Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans. Volunteers given written information about the process and given time to consider participation. Once any questions have been answered, fully informed written consent obtained if they are interested in taking part. At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment. The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will at 12 months. Radiographic assessment including cone beam computed tomography (CBCT) will be done at baseline and 12 months. It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of patients, each group received the investigated intervention at baseline and being followed up in parallel for one year.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of a New Protocol for Indirect Pulp Capping Procedures
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Active Comparator: Control
the conventional protocol in indirect pulp capping include the use of mechanical rotary burs for caries removal in teeth with reversible pulpitis.
Device: Mechanical rotary burs
A rotary drill made of steel or diamond impregnated materials attached to a steel shank, available in varying degree of sharpness, lengths and sizes used conventionally in preparation of teeth to receive a dental restoration.

Experimental: Conservative
the conservative protocol of indirect pulp capping include the use of Carisolv gel for caries removal in teeth with reversible pulpitis.
Device: Carisolv gel
A chemical gel made of a combination of amino acids and sodium hypochlorite used with hand instruments to soften and remove the decay to prepare the tooth to receive a dental restoration.

Primary Outcome Measures :
  1. cold pulp test (signalling the nerve of the pulp of the tooth by cold application) [ Time Frame: One year follow up ]
    Binary variable outcome measure whether the nerve is positively or negatively responsive to the cold test.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Clinical diagnosis of reversible pulpitis with positive response to cold pulp test.

Exclusion Criteria:

Clinical diagnosis of irreversible pulpitis, Pregnant women, mobile teeth and teeth with tenderness to percussion.

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 identifier (NCT number): NCT03071588

Sponsors and Collaborators
King's College London
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Principal Investigator: Francesco Mannocci King's College London
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: King's College London Identifier: NCT03071588    
Other Study ID Numbers: 14/LO/0880
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
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
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases