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Treatment of deep carious lesions in permanent teeth of adults

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2011/011
Enrollment
Unknown
Registered
2011-09-21
Start date
2011-09-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversible Pulpitis

Interventions

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 fo
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 cappi

Sponsors

Ministry of Higher Education
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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] 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

MeasureTime frame
No sign and symptom (including pain) in the treated tooth. [Immediately after the treatment up to one week]

Countries

Sri Lanka

Contacts

Public ContactDr. K.M. Wijerathne

Senior Lecturer

kmw@pdn.ac.lk081 2388 948

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026