Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Launched by ÇANAKKALE ONSEKIZ MART UNIVERSITY · Feb 5, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different treatments for children with dental issues in their primary molars, specifically when the tooth pulp (the soft tissue inside the tooth) is damaged or infected. The study aims to compare the traditional method of root canal treatment with a newer technique called lesion sterilization tissue repair. Both treatments are meant to help relieve pain and save the tooth.
To be eligible for this study, children must be between the ages of 3 and 8 years and have specific dental problems, such as severe tooth pain or an infection in their molars. They also need to be generally healthy and able to cooperate during the treatment. Parents will be asked to sign consent forms to ensure they understand what the study involves. If selected, participants can expect to receive one of the two treatments and will be monitored to see how well each method works in fixing their dental issues. This trial is not yet recruiting participants, but it aims to help improve dental care for young children in the future.
Gender
ALL
Eligibility criteria
- 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.
About çanakkale Onsekiz Mart University
Çanakkale Onsekiz Mart University is a leading academic institution in Turkey, recognized for its commitment to advancing healthcare through innovative research and clinical trials. The university actively engages in various clinical studies aimed at enhancing medical knowledge and improving patient outcomes. With a team of experienced researchers and state-of-the-art facilities, Çanakkale Onsekiz Mart University fosters collaboration between disciplines to address critical health challenges and contribute to the global medical community. Its dedication to ethical research practices and patient safety underscores its role as a trusted sponsor in the clinical trial landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Canakkale, Kepez, Turkey
Patients applied
Trial Officials
Sümeyye Şenol, R.A.
Principal Investigator
Canakkale Onsekiz Mart University
Berkant Sezer, Assoc. Prof.
Principal Investigator
Canakkale Onsekiz Mart University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported