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NCT07607314
Rotary Versus Manual Degranulation in Alveolar Ridge Preservation
Conditions: Chronic Periapical Periodontitis, Alveolar Ridge Preservation
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Imam Abdulrahman Bin Faisal University
Location: College of Dentistry, Imam Abdulrahman Bin Faisal University Dammam Dammam
Summary
After a tooth is taken out, the empty socket needs to heal. Sometimes unhealthy soft tissue (called granulation tissue) is left behind and can slow down healing. This study compares two ways to clean the socket:
1. Manual method: a hand instrument (curette)
2. Rotary method: a small rotating dental bur
Both methods are standard in dental practice. The study will see which method is faster, causes less pain, and leads to better bone healing. After cleaning, all patients will receive a routine bone graft to protect the jawbone for a possible future dental implant.
The study will measure:
* How long (in seconds) it takes to clean the socket
* A harmless blue stain (Toluidine Blue) was used during cleaning to show any unhealthy tissue left behind, and cleaning continued until no stain remained; the stain showed when to stop rather than being measured on its own
* Changes in the bone at 3 and 6 months, measured by a special three-dimensional X-ray (cone-beam computed tomography, CBCT)
* Pain and swelling reported by patients in the first week after the procedure
* Any side effects or healing problems
Each extraction site is randomly assigned to one of the two cleaning methods (like flipping a coin), so a patient having two teeth treated may receive a different method at each. The surgeon knows which method is used, but the person analyzing the X-rays does not, to keep the results fair.
The study included 50 adult patients and 60 extraction sites. Some patients had two teeth treated, at separate appointments. It is being conducted at the College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Eligibility Criteria
Inclusion Criteria:
* Patients will be recruited from those attending the outpatient clinics of the College of Dentistry.
* Adults aged 18-65 years of American Society of Anesthesiologists (ASA) physical status I, presenting with a tooth indicated for extraction due to chronic periapical pathology (e.g., periapical granuloma or cystic lesion) confirmed clinically and radiographically.
* All cases must be verified with a cone-beam computed tomography (CBCT) scan demonstrating periapical pathology with intact socket walls and sufficient residual alveolar bone to allow for ridge preservation. A 10 x 10 cm volume covering both jaws is required, because the vertical reference landmarks for the radiographic outcome are the inferior border of the mandible and the floor of the maxillary sinus or nasal cavity.
* Only teeth with single or multi-rooted lesions indicated for atraumatic extraction without excessive bone removal will be considered.
* Participants must also be capable of providing informed consent, demonstrate adequate oral hygiene, and be willing to return for scheduled follow-up visits.
Exclusion Criteria:
* Acute odontogenic infection at the extraction site.
* Thin buccal bone (\< 1mm on CBCT).
* Severe periodontal breakdown with more than 50% bone loss.
* Grade III mobility.
* Root morphology that limits instrument accessibility.
* Any systemic condition placing the patient above ASA I.
* Pregnant or lactating women.
* Medications known to affect bone metabolism such as long-term corticosteroids or bisphosphonates.
* Self-reported or documented allergy to penicillin or amoxicillin.
* Poor oral hygiene, inability to maintain adequate postoperative care, or unwillingness to attend scheduled follow-up visits.
Source: ClinicalTrials.gov (NCT07607314). StuddyBuddy aggregates publicly available trial information.