Lesion sterilization and tissue repairConventional pulpectomy
Lesion sterilization and tissue repair: Lesion sterilization and tissue repair therapy performed with a triple antibiotic mixture.
Conventional pulpectomy: Conventional pulpectomy with calcium hydroxide-iodoform based root canal paste.
Study 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.
Eligibility
Sex
ALL
Min age
3 Years
Max age
8 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Clinical success — 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 — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Canakkale Onsekiz Mart University
Çanakkale
Kepez
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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