Clinical and Radiographic Evaluation of Lesion Sterilization With Triple Antibiotic Paste Versus Root Canal Treatment With Calcium Hydroxide-iodoform Paste in Mandibular Primary Molars Diagnosed With Necrotic Pulp or Irreversible Pulpitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Clinical success
Study Overview
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.
Detailed Description
The study will be conducted on children aged 3-8 years who present to the Department of Pediatric Dentistry at Çanakkale Onsekiz Mart University, Faculty of Dentistry. The aim of the study is to compare the clinical and radiographic success of conventional root canal treatment using a calcium hydroxide-iodoform-based root canal paste and lesion sterilization tissue repair (LSTR) therapy using a triple antibiotic mixture of metronidazole, ciprofloxacin, and clindamycin in mandibular primary molars diagnosed with necrotic or irreversible pulpitis, meeting the inclusion and exclusion criteria.
The null hypothesis of the study is that there will be no significant difference in clinical and radiographic success between conventional root canal treatment and lesion sterilization tissue repair at any follow-up period.
The study plans to enroll 37 (thirty-seven) participants in the research group and 37 (thirty-seven) participants in the comparison group. The sample size was calculated based on the parameters derived from the study by Moura et al., which compared the clinical and radiographic success of conventional root canal treatment using zinc oxide eugenol and lesion sterilization tissue repair using a triple antibiotic paste. With a power level of 0.8, an alpha error probability of 0.05, and an effect size of 0.4020915, the required sample size was determined using the G*Power 3.0.10 software (v.3.1.9.7, Universitat Kiel, Kiel, Germany).
In the comparison group, conventional pulpectomy (root canal treatment) using a calcium hydroxide-iodoform-based root canal filling paste will be performed on the teeth. In the research group, lesion sterilization tissue repair therapy will be carried out using a triple antibiotic mixture of metronidazole, ciprofloxacin, and clindamycin.
The common procedural steps for both groups will include:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
study group
Lesion sterilization and tissue repair
Intervention: Lesion sterilization and tissue repair (Procedure)
control group
Conventional pulpectomy
Intervention: Conventional pulpectomy (Procedure)
Outcomes
Primary Outcomes
Clinical success
Time Frame: Follow up will be for three year with recall visits at 1, 3, 6, 12, 18, 24, 30 and 36 months.
* 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
Miller Classification - Tooth Mobility
Time Frame: 1, 3, 6, 12, 18, 24, 30, and 36 months.
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).
Radiographic success
Time Frame: Follow up will be for three year with recall visits at 1, 3, 6, 12, 18, 24, 30 and 36 months.
* Absence of furcation or periapical radiolucency. * Absence of change in the extent of internal or external root resorption other than physiologic resorption.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sümeyye ŞENOL
Research Assistant
Çanakkale Onsekiz Mart University