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Management of Deep Carious Lesions in Adults

Primary Purpose

Caries, Reversible Pulpitis

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Selective caries excavation
Non selective caries excavation
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries focused on measuring Deep caries, Reversible pulpitis, Selective excavation, Nonselective excavation, Biodentine

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The patient age (16-60) years old
  • Non -contributory medical history
  • Deep caries extending>= 2/3 of dentine but not exposing the pulp on the radiograph
  • The tooth should give positive response to cold testing
  • Clinical diagnosis of reversible pulpitis
  • The tooth is restorable, probing pocket depth and mobility are within normal limits
  • No signs of pulpal necrosis including sinus tract or swelling
  • No radiographic evidence of periapical changes indicative of apical periodontitis

Exclusion Criteria:

  • Immature roots
  • caries exposing the pulp on radiograph
  • symptoms of irreversible pulpits
  • In ability to control bleeding after pulp exposure

Sites / Locations

  • Jordan University of science and technologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Selective excavation

Non selective excavation

Arm Description

Cries will be removed from the peripheries of the cavity, while only soft caries will be removed from the plural side leaving stained leathery dentine that can not be removed by hand instruments. Biodentine will be placed and the cavity will be restored.

Caries will be cleaned form all cavity peripheries and floor. Biodentine will be placed and the toothy will be restored.

Outcomes

Primary Outcome Measures

Absence of clinical symptoms
Relief of pain after the procedure

Secondary Outcome Measures

Pulp vitality
Absence of clinical and radiographic signs of pulp pathosis, in addition to normal response to cold testing

Full Information

First Posted
November 22, 2021
Last Updated
September 10, 2022
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05144711
Brief Title
Management of Deep Carious Lesions in Adults
Official Title
Selective Versus Nonselective Caries Excavation in Adults: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dental caries is one of the most prevalent non-communicable disease. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete nonselective excavation suggests there may be benefit for selective removal in sustaining tooth vitality while histological studies reveal that the remaining dentine is actually infected and may cause loss of vitality in long term. The aim of this study is to randomly compare selective to non-elective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis
Detailed Description
The aim of this study is to randomly compare selective to nonselective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis over 4 years. Cases will be collected from the initial treatment unit and the undergraduate clinics over a 8 months' period, the minimum sample size required is 120 teeth in 120 patients for an assumed difference of 20% in the success rate and accounting for 20% wear rate in the follow up, randomization will be performed using tabular randomization. Intensity of pulp symptoms will be recorded, patient's description of sensitivity to hot/cold/sweet lasting up to 15-20s and settling spontaneously are considered mild, while increased pain for more than several minutes and needing pain killers are considered severe. Inclusion criteria: The patient age (16-60) years old Non -contributory medical history Deep caries extending>= 2/3 of dentine but not exposing the pulp on the radiograph The tooth should give positive response to cold testing Clinical diagnosis of reversible pulpitis The tooth is restorable, probing pocket depth and mobility are within normal limits No signs of pulpal necrosis including sinus tract or swelling No radiographic evidence of periapical changes indicative of apical periodontitis Preoperative pulpal and periapical diagnosis will be established after clinical examination including soft tissue palpation, percussion, and cold testing (, and digital periapical and bitewing radiographs will be taken using film holders and a paralleling technique. Baseline characteristics of the patient (age, gender) and the treated tooth (number, position, caries extension) will be recorded. Each tooth will be randomly allocated for the choice of treatment with selective or nonselective caries excavation according to a random sequence number generator. Clinical procedure: The clinical procedure will be performed by one calibrated postgraduate student under supervision. The tooth will be anesthetized with , rubber dam will be applied and the tooth crown will be disinfected with 5% NaOCl before caries excavation; The cases will be divided randomly into: Group 1: One-stage selective carious-tissue removal to soft or firm dentine, using carbon-steel rose- head burs (ash instruments) in a slow speed headpiece, the excavation end point is the detection of leathery dentine using a sharp dental explorer and excavator. Group 2: Non-selective carious-tissue removal. The tooth will be isolated with rubber dam and disinfected with NaOCl. Complete caries excavation will be removed from the entire cavity, inspection under the microscope will be done to identify pulp exposure. If no pulp exposure is evident Biodentine will be placed and the cavity will be restored with composite. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be the choice of the treatment. The bleeding will be controlled via gentle pressure with a cotton pellet soaked with 2.5% NaOCl over the pulpal wound for 2 minutes and repeated if required up to 5 times. In both groups, 2mm of Biodentine will be used and vitrebond will be placed as a liner on top, this will be followed by etching with 37% orthophosphoric acid, rinsing with water, and then bonding with adhesive followed by the placement of resin composite. Flowable composites will be used in deep cavities if needed. Clinical and radiographic success will be evaluated at 6 months, 1 year, 2 years and 4 years postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Reversible Pulpitis
Keywords
Deep caries, Reversible pulpitis, Selective excavation, Nonselective excavation, Biodentine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cases randomly assigned into the two groups using a block method
Masking
ParticipantOutcomes Assessor
Masking Description
An informed consent will be obtained from the participant but he will not be informed whether selective or non selective excavation was done for him. the outcome assessor will be blinded to the procedure, and if required masking of the crowns of teeth on radiographs will be done before evaluation.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selective excavation
Arm Type
Active Comparator
Arm Description
Cries will be removed from the peripheries of the cavity, while only soft caries will be removed from the plural side leaving stained leathery dentine that can not be removed by hand instruments. Biodentine will be placed and the cavity will be restored.
Arm Title
Non selective excavation
Arm Type
Active Comparator
Arm Description
Caries will be cleaned form all cavity peripheries and floor. Biodentine will be placed and the toothy will be restored.
Intervention Type
Procedure
Intervention Name(s)
Selective caries excavation
Intervention Description
Selective caries excavation leaving stained but leathery dentine towards the pulp
Intervention Type
Procedure
Intervention Name(s)
Non selective caries excavation
Intervention Description
Complete excavation of caries regardless of the risk of pulp exposure
Primary Outcome Measure Information:
Title
Absence of clinical symptoms
Description
Relief of pain after the procedure
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pulp vitality
Description
Absence of clinical and radiographic signs of pulp pathosis, in addition to normal response to cold testing
Time Frame
6, 12, 24, 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The patient age (16-60) years old Non -contributory medical history Deep caries extending>= 2/3 of dentine but not exposing the pulp on the radiograph The tooth should give positive response to cold testing Clinical diagnosis of reversible pulpitis The tooth is restorable, probing pocket depth and mobility are within normal limits No signs of pulpal necrosis including sinus tract or swelling No radiographic evidence of periapical changes indicative of apical periodontitis Exclusion Criteria: Immature roots caries exposing the pulp on radiograph symptoms of irreversible pulpits In ability to control bleeding after pulp exposure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nessrin Taha, PhD
Phone
962776566110
Email
n.taha@just.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nessrin Taha, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of science and technology
City
Irbid
ZIP/Postal Code
21110
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nessrin Taha, PhD
Phone
(62776566110
Email
n.taha@just.edu.jo
Phone
+962776566110
Email
nessrin_taha@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
When recruitment is completed and the data is analyzed and submitted for publication. Data may be provided for the benefit of other researchers.
Citations:
PubMed Identifier
32950193
Citation
Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.
Results Reference
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Management of Deep Carious Lesions in Adults

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