Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars

NCT06811636 | Active Not Recruiting

• 1 other identifier: CanakkaleOMU1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the clinical and radiographic success of conventional root canal treatment and lesion sterilisation tissue repair methods in deciduous molars with necrotic or irreversible pulpitis.

Conditions

Pulp Necroses; Pulpitis - Irreversible; Root Canal Infection

Keywords

Lesion Sterilization Tissue Repair; Conventional Pulpectomy

Outcome Measures

Primary Outcomes (3)

• Clinical success

  * Absence of spontaneous pain. * Absence of sensitivity to percussion using dental mirror, pain on biting. * Absence of swelling. * Absence of fistula / Exudate. * Absence of non-physiological mobility

  Follow up will be for three year with recall visits at 1, 3, 6, 12, 18, 24, 30 and 36 months.

• Miller Classification - Tooth Mobility

  Class 0 Normal (physiologic) movement when force is applied. Class I Mobility greater than physiologic. Class II Tooth can be moved up to 1mm or more in a lateral direction (buccolingual or mesiodistal). Inability to depress the tooth in a vertical direction (apicocoronal). Class III Tooth can be moved 1mm or more in a lateral direction (buccolingual or mesiodistal). Ability to depress the tooth in a vertical direction (apicocoronal).

  1, 3, 6, 12, 18, 24, 30, and 36 months.

• Radiographic success

  * Absence of furcation or periapical radiolucency. * Absence of change in the extent of internal or external root resorption other than physiologic resorption.

  Follow up will be for three year with recall visits at 1, 3, 6, 12, 18, 24, 30 and 36 months.

Study Arms (2)

study group

EXPERIMENTAL

Lesion sterilization and tissue repair

Procedure: Lesion sterilization and tissue repair

control group

ACTIVE COMPARATOR

Conventional pulpectomy

Procedure: Conventional pulpectomy

Interventions

Conventional pulpectomy PROCEDURE

Conventional pulpectomy with calcium hydroxide-iodoform based root canal paste.

control group

Lesion sterilization and tissue repair PROCEDURE

Lesion sterilization and tissue repair therapy performed with a triple antibiotic mixture.

study group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The participant is between the ages of 3 and 8 years.
• The participant and their parent(s) have signed informed consent forms agreeing to participate in the study.
• The patient is systemically healthy.
• The patient's cooperation level is sufficient for performing the procedures.
• No history of allergic reactions to the materials and substances to be used.
• Mandibular primary molars diagnosed with pulp necrosis or irreversible pulpitis.
• Presence of endodontic-origin gingival abscess or fistula in the involved teeth.
• History of spontaneous pain.
• Presence of radiolucency in the furcation or periapical region, not exceeding one-third of the affected area.
• Presence of deep dentin caries causing pulp exposure.
• Presence of mobility at level 0 or 1 according to Miller's classification (non-pathologic).
• The tooth meets the criteria for restorability.
• Root resorption does not exceed more than four-fifths of the root.
• The tooth meets the criteria for isolation.

You may not qualify if:

• The participant is not between the ages of 3 and 8 years.
• The participant and/or their parent(s) have not agreed to participate in the study or have not signed the informed consent forms.
• The patient has a systemic disease.
• The patient's cooperation level is insufficient to perform the procedures.
• The patient has a history of allergic reactions to the materials and substances to be used.
• Teeth with external or internal root resorption.
• Mechanical or carious perforation of the pulp floor in the affected teeth.
• Radiolucency and bone destruction in the furcation or periapical region exceeding one-third of the affected area.
• Presence of caries that does not cause pulp exposure.
• Pathological mobility according to Miller's classification (\>1 score).
• The tooth does not meet the criteria for restorability.
• Root resorption exceeds more than four-fifths of the root.
• The tooth does not meet the criteria for isolation.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Kepez, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Sümeyye Şenol, R.A.

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

• Berkant Sezer, Assoc. Prof.

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 6, 2025
• Study Start: April 30, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)