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NCT Number: NCT07120009

Partial Pulpotomy vs Selective Removing in Deep Caries

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Selective caries removal

Procedure

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

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.

Primary outcomes

  1. Assessment of pain

    Time frame: 6th and 12th month

    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.
  2. Periapical pathology

    Time frame: 6th and 12th month

    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.

  3. Tenderness to percussion

    Time frame: 12th month

    • Usually, the back of a dental mirror handle or the handle of a periodontal probe is used.
    • 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.
    • It is compared with other teeth in the same area. If the pain is only in one tooth, it suggests pathology.
    • The patient describes the pain as "aching," "discomfort," or "severe pain." This severity indicates the severity of the inflamation

Study contacts

Contact information is provided by the study sponsor or research team.

zeliha g bek kurklu

CONTACT

[email protected]

+905334500892

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Selective Caries Removal Versus Partial Pulpotomy in the Treatment of Deep Caries: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.