Treatment of deep carious lesions in permanent teeth of adults

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2011/011
• Date of registration: 21/09/2011
• Primary sponsor: Ministry of Higher Education
• Public title: Treatment of deep carious lesions in permanent teeth of adults
• Scientific title: 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 pulpotomy.
• Date of first enrolment: 23/9/2011
• Target sample size: Total number of teeth 1575
• Recruitment status: Pending
• URL: http://www.slctr.lk/trial_details.asp?reg_id={6C13518C-48E2-4FFB-B085-2B1BE549A250}
• Study type: Interventional
• Study design: 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.

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. K.M. Wijerathne
• Affiliation: Senior Lecturer

• Name: Prof R. L. Wijeyeweera
• Affiliation: Professor in Peadodontics

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Reversible Pulpitis

Intervention(s)

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.

Primary Outcome(s)

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


2. Pulp capping trial : pulp status, periapical status and pain (pulp vitality without apical radiolucency =success).

Secondary Outcome(s)

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

Secondary ID(s)

Nil known

Source(s) of Monetary Support

HTEC and ICD grants from UGC

Secondary Sponsor(s)

University Grant Commission