Assessment of a New Protocol for Indirect Pulp Capping Procedures
Primary Purpose
Reversible Pulpitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical rotary burs
Carisolv gel
Sponsored by
About this trial
This is an interventional treatment trial for Reversible Pulpitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Conservative
Arm Description
the conventional protocol in indirect pulp capping include the use of mechanical rotary burs for caries removal in teeth with reversible pulpitis.
the conservative protocol of indirect pulp capping include the use of Carisolv gel for caries removal in teeth with reversible pulpitis.
Outcomes
Primary Outcome Measures
cold pulp test (signalling the nerve of the pulp of the tooth by cold application)
Binary variable outcome measure whether the nerve is positively or negatively responsive to the cold test.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03071588
Brief Title
Assessment of a New Protocol for Indirect Pulp Capping Procedures
Official Title
Assessment of a New Protocol for Indirect Pulp Capping Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of patients, each group received the investigated intervention at baseline and being followed up in parallel for one year.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
the conventional protocol in indirect pulp capping include the use of mechanical rotary burs for caries removal in teeth with reversible pulpitis.
Arm Title
Conservative
Arm Type
Experimental
Arm Description
the conservative protocol of indirect pulp capping include the use of Carisolv gel for caries removal in teeth with reversible pulpitis.
Intervention Type
Device
Intervention Name(s)
Mechanical rotary burs
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Carisolv gel
Intervention Description
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 Measure Information:
Title
cold pulp test (signalling the nerve of the pulp of the tooth by cold application)
Description
Binary variable outcome measure whether the nerve is positively or negatively responsive to the cold test.
Time Frame
One year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Mannocci
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32854206
Citation
Ali AH, Thani FB, Foschi F, Banerjee A, Mannocci F. Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results. J Clin Med. 2020 Aug 25;9(9):2738. doi: 10.3390/jcm9092738.
Results Reference
derived
PubMed Identifier
29738286
Citation
Ali AH, Koller G, Foschi F, Andiappan M, Bruce KD, Banerjee A, Mannocci F. Self-Limiting versus Conventional Caries Removal: A Randomized Clinical Trial. J Dent Res. 2018 Oct;97(11):1207-1213. doi: 10.1177/0022034518769255. Epub 2018 May 8.
Results Reference
derived
Learn more about this trial
Assessment of a New Protocol for Indirect Pulp Capping Procedures
We'll reach out to this number within 24 hrs