Home » Trials » Trial #37 » original TRDS
SLCTR Registration Number
SLCTR/2011/011
Date of Registration
The date of last modification
Jul 29, 2012
View original TRDS
Trial Status
Scientific Title of Trial
Two year evaluation of pulp status after treatment of deep carious lesions in the permanent posterior teeth of adults: a randomized clinical trial comparing indirect pulp capping vs. Stepwise vs. Complete excavation, and direct pulp capping vs. Partial pu
Public Title of Trial
Treatment of deep carious lesions in permanent teeth of adults
Disease or Health Condition(s) Studied
Reversible Pulpitis
Scientific Acronym
None
Public Acronym
None
Brief title
Randomized controlled clinical trial of pulp capping and partial pulpotomy
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Intervention(s) planned
1.Excavation component (excavation trial) : The effects of superficial removal of deep carious lesions vs. stepwise vs. direct complete excavation restored with either a Calcium Hydroxide liner and Glass Ionomer base plus composite restoration, Glass Ionomer base plus composite restoration or Biodentine base plus composite restoration. The outcome measure will be pulp exposure, 2-year pulp status, 2-year periapical status and 2-year pain; 2. Pulp capping component (pulp capping trial) : Direct capping vs. partial pulpotomy of savable (reversibly inflamed) pulps exposed as a result of caries removal and restored with either a pulp capping of Calcium Hydroxide liner and Glass Ionomer base plus composite restoration, Mineral Trioxide Aggregate and Glass Ionomer plus composite restoration or Biodentine plus composite restoration. The outcome measure will be 2-year pulp status, 2-year periapical status and 2-year pain.
Inclusion criteria
⢠18 years or older healthy males and females; ⢠A primary carious lesion radiographically involving a penetration depth of 75% or more of the dentine with a pulp that is deemed to be savable and only reversibly inflamed; ⢠In patients who report pain, the pain should be provoked and confirmed by stimulation with cold or compressed air (pretreatment pain); ⢠⢠Availability for the two years duration of the study; ⢠Good general health with no known allergy to products being tested.
Exclusion criteria
⢠No response to cold and electrical pulp testing indicating pulp necrosis; ⢠Pus draining from the exposed pulp indicating (partial) pulp necrosis; ⢠Inability to stop bleeding from the exposed pulp with simple means; ⢠Non-bleeding pulp indicating (partial) pulp necrosis; ⢠Periapical radiolucency; ⢠Periodontal attachment loss > 5 mm apical; ⢠Pregnancy; any systemic disease preventing enrolment; ⢠⢠History of known allergy to materials use; ⢠Patients who are unable to comply with study appointment schedule.
Primary outcome(s)
|
1.
|
[ At 1 year and 2 years after the procedure ] |
|
2.
Pulp capping trial : pulp status, periapical status and pain (pulp vitality without apical radiolucency =success). |
[ At 1 year and 2 years after the procedure ] |
Secondary outcome(s)
|
1.
|
[ Immediately after the treatment up to one week ] |
Target number/sample size
Total number of teeth 1575
Countries of recruitment
Anticipated start date
2011-09-23
Anticipated end date
2013-09-22
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
HTEC and ICD grants from UGC
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Dr. K.M. Wijerathne
Senior Lecturer
Department of Restorative Dentistry, Faculty of Dental Sciences, University of Peradeniya
081 2388 948
0777 801 317
kmw@pdn.ac.lk
Primary study sponsor/organization
Ministry of Higher Education
HETC Project, 23/135, Diyawanna gardens, Chandra de Silva MW, Nugegoda
0112 814 279 0112 814 283
ppdu@hetc.lk
www.hetc.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
