Home » Trials » SLCTR/2011/011


Two year evaluation of pulp status after treatment of deep carious lesions in permanent posterior teeth of adults: a randomized clinical trial comparing indirect pulp capping vs.Stepwise vs.Complete excavation, & direct pulp capping vs. Partial pulpotomy

-

SLCTR Registration Number

SLCTR/2011/011


Date of Registration

21 Sep 2011

The date of last modification

Mar 03, 2019


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

Two year evaluation of pulp status after treatment of deep carious lesions in permanent posterior teeth of adults: a randomized clinical trial comparing indirect pulp capping vs.Stepwise vs.Complete excavation, & direct pulp capping vs. Partial pulpotomy


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

FDS-FRC/2011/01 (Faculty Research Committee, Faculty of Dental Sciences, University of Peradeniya)


Trial Details


What is the research question being addressed?

  1. What is the effect of superficial removal of deep carious lesions vs. stepwise vs. direct complete excavation on pulp exposure, 2-year pulp status, 2-year periapical status and 2-year pain?
  2. What is the effect of Direct capping vs. partial pulpotomy on 2-year pulp status, 2-year periapical status and 2-year pain?

Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Available


Intervention(s) planned

The randomized controlled trial will be conducted using a computer-generated randomization list with nine groups of patient-blinded volunteers for the excavation trial. Trial will include 375 teeth for each procedure and a total of 1125 teeth. Patients will be unaware of the treatment assigned. If the procedure to remove caries leads to pulp exposure, the patient will be assessed for eligibility for the pulp capping trial. 75 patients for each of the six groups and a total of 450 teeth are necessary. Eligible patients will be centrally randomized to either the direct pulp capping or partial pulpotomy.

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.

Excavation trial : pulp exposure, pulp status, periapical status and pain (unexposed pulps with sustained pulp health without apical radiolucency = success)

[

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.

No sign and symptom (including pain) in the treated tooth.

[

Immediately after the treatment up to one week

]

Target number/sample size

Total number of teeth 1575


Countries of recruitment

Sri Lanka


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



State of Ethics Review Approval


Status

Approved


Date of Approval

2011-02-23


Approval number

FDS-FRC/2011/01


Details of Ethics Review Committee

Name: Research and Ethical Review Committee, Faculty of Dental Sciences, University of Peradeniya
Institutional Address:Peradeniya, 20400, Sri Lanka
Telephone:+94-812397552
Email: sunethraj@pdn.ac.lk

Contact & Sponsor Information


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

Contact Person for Public Queries

Prof R. L. Wijeyeweera
Professor in Peadodontics
Division of Peadodontics, Faculty of Dental Sciences, University of Peradeniya





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

Secondary study sponsor (If any)

None





Trial Completion details


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

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results