Partial Pulpotomy vs Selective Removing in Deep Caries

NCT07120009 | Not Yet Recruiting

• 1 other identifier: cu dişhekimligi
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to compare the one-year results of selective caries removal and partial pulpotomy treatments in terms of pulp survival and the need for further endodontic treatment in deep carious lesions.Individuals aged 18-65 years with medically healthy mature permanent teeth with deep caries will be included. The included teeth will be randomly assigned to the selective caries removal or partial pulpotomy group. Follow-up evaluations will be performed at 6 months and 12 months. The main outcome is pulp survival as determined by clinical and radiographic success.

Conditions

Deep Dentin Caries in Mature Permanent Teeth

Keywords

Vital pulp therapy; Deep caries; Selective caries removal; Partial pulpotomy

Outcome Measures

Primary Outcomes (3)

• Assessment of pain

  Detailed medical history * Is the pain constant or intermittent? * How severe is the pain? The outcome will be evaluated using the Visual Analog Scale (VAS), which ranges from 0 to 10, with higher scores indicating a worse outcome.

  6th and 12th month

• Periapical pathology

  Standardized digital periapical radiographs will be taken using the long cone paralleling technique to assess periapical status, presence of radiolucent lesions, and periodontal ligament space. Radiographs will be obtained at baseline, 6 months, and 12 months to monitor treatment outcomes and detect any pathological changes.

  6th and 12th month

• Tenderness to percussion

  1. Usually, the back of a dental mirror handle or the handle of a periodontal probe is used. 2. First, vertical percussion (lightly tapping the occlusal surface from above) is performed, followed by lateral percussion (lightly tapping the side of the tooth) if necessary. 3. It is compared with other teeth in the same area. If the pain is only in one tooth, it suggests pathology. 4. The patient describes the pain as "aching," "discomfort," or "severe pain." This severity indicates the severity of the inflamation

  12th month

Study Arms (2)

selective caries removal

EXPERIMENTAL

Deep caries lesions will be treated with selective caries removal and followed up

Procedure: selective caries removal

partial pulpotomy

EXPERIMENTAL

Deep caries lesions will be treated with partial pulpotomy and followed up

Procedure: partial pulpotpmy

Interventions

selective caries removal PROCEDURE

The caries is not completely removed but covered with a remineralizing material. Its purpose is to maintain pulp vitality.

selective caries removal

partial pulpotpmy PROCEDURE

Complete cleaning of the caries resulting in pulp expose. pulp tissue is surgically removed by 1-3 mm.The aim is to remove the inflamed superficial pulp tissue to allow healing from the underlying healthy tissue.

partial pulpotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-65
• ASA I or II general health status
• Deep primary or secondary caries lesion (up to 75% dentin thickness)
• Restorable permanent teeth with mature apex
• Teeth without clinical and radiographic periapical pathology

You may not qualify if:

• Pregnancy
• Periapical lesion
• Spontaneous pain or tenderness to palpation
• Teeth for which pulp opening or crown/root supported prosthesis is planned
• Localized severe periodontitis

Sponsors & Collaborators

• Cukurova University: lead

Related Publications (1)

• Chua SKX, Sim YF, Wang WC, Mok BYY, Yu VSH. One-year outcome of selective caries removal versus pulpotomy treatment of deep caries: A pilot randomized controlled trial. Int Endod J. 2023 Dec;56(12):1459-1474. doi: 10.1111/iej.13978. Epub 2023 Oct 5.

  PMID: 37795835 BACKGROUND

Central Study Contacts

zeliha g bek kurklu

CONTACT

+905334500892; goncabek@mynet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share