Rotary Versus Manual Degranulation in Alveolar Ridge Preservation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorImam Abdulrahman Bin Faisal University
About this trial
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 * Whether the socket is completely clean, checked with a harmless blue stain (Toluidine Blue) * 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
Patients are randomly assigned to one of the two cleaning methods (like flipping a coin). The surgeon knows which method is used, but the person analyzing the X-rays does not, to keep the results fair.
The study will include 58-60 adult patients who need a tooth removed because of a long-term infection at the root. It is being conducted at the College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients will be recruited from those attending the outpatient clinics of the College of Dentistry.
Systemically healthy adults aged 18-65 years who present with teeth 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 tooth-specific, limited field-of-view cone-beam computed tomography (CBCT) scan to minimize radiation exposure and to demonstrate the presence of periapical pathology with intact socket walls and sufficient residual alveolar bone to allow for ridge preservation.
Only teeth with single or multi-rooted lesions indicated for atraumatic extraction without excessive bone removal will be considered.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rotary Degranulation
Procedure/SurgeryDegranulation of the extraction socket using a 2.5mm super coarse diamond bur at 1000-1200 RPM, followed by standardized alveolar ridge preservation with allograft and collagen membrane.
Manual Curettage
Procedure/SurgeryDegranulation of the extraction socket using a #85 Lucas surgical curette 2.5mm, followed by standardized alveolar ridge preservation with allograft and collagen membrane.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Rotary DegranulationExperimental treatment 1 intervention
Group B: Manual CurettageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Operative time (seconds)
Time from instrument engagement (rotary bur or manual curette) until the surgeon declares the socket clinically stain-free and free of any soft tissue, confirmed by Toluidine Blue staining. Measured by a second assistant using a digital timer.
Time frame
During the degranulation procedure (Day 0)Secondary outcomes
1
Toluidine blue stain-free socket rate
Proportion of extraction sockets achieving a Toluidine blue (TB) stain-free status after a single debridement cycle, immediately following the procedure, as an indicator of degranulation efficiency.
Time frame
Immediately after debridement (Day 0)2
Cone-beam computed tomography-measured socket volume reduction
Change in alveolar ridge dimensions (height and width) measured by cone-beam computed tomography (CBCT) at 3 and 6 months post-extraction.
Time frame
3 and 6 months post-extraction3
Patient-reported pain and swelling
Patient-reported post-operative pain measured by visual analog scale (VAS) for pain (range 0-10, where 0=no pain and 10=worst pain; higher scores indicate worse outcome) and facial swelling index during the first 7 postoperative days.
Time frame
First 7 postoperative days4
Postoperative complications
Incidence of postoperative complications including infection, delayed healing, membrane exposure, and graft loss.
Time frame
Up to 6 months post-extractionSponsors and contacts
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Source ClinicalTrials.gov