Rotary Versus Manual Degranulation in Alveolar Ridge Preservation

NCT07607314 | Active Not Recruiting

• 1 other identifier: 26041403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Chronic Periapical Periodontitis; Alveolar Ridge Preservation

Keywords

Degranulation; Rotary instrument; Manual curettage; Alveolar ridge preservation; Granulation tissue; Chronic periapical periodontitis

Outcome Measures

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 the second assistant using a digital stopwatch (HS-3V-1R, Casio Computer Co.,Tokyo, Japan) and recorded to the nearest second.

  During the degranulation procedure (Day 0)

Secondary Outcomes (5)

• Toluidine blue stain-free socket rate

  Immediately after debridement (Day 0)

• Cone-beam computed tomographic change in alveolar ridge dimensions

  3 and 6 months post-extraction

• Patient-reported pain and swelling

  First 7 postoperative days

• Postoperative complications

  Up to 6 months post-extraction

• Intraoperative complications

  During the procedure (Day 0)

Study Arms (2)

Rotary Degranulation

EXPERIMENTAL

Granulation tissue removed with a 2.5 mm super-coarse diamond degranulation bur at 1,000 RPM at the bur (1:1 contra-angle handpiece). After debridement, alveolar ridge preservation with allograft and collagen membrane.

Procedure: Rotary Degranulation

Manual Curettage

ACTIVE COMPARATOR

Granulation tissue removed with a #85 Lucas surgical curette 2.5mm. After debridement, alveolar ridge preservation with allograft and collagen membrane.

Procedure: Manual Curettage

Interventions

Rotary Degranulation PROCEDURE

Degranulation of the extraction socket using a 2.5 mm super-coarse diamond degranulation bur at 1,000 RPM at the bur (1:1 contra-angle handpiece), followed by standardized alveolar ridge preservation with allograft and collagen membrane.

Also known as: 2.5 mm super-coarse diamond degranulation bur (ISO 801LD.RAXL.025, Degranulation Kit 1454, Jota AG, Rüthi, Switzerland)

Rotary Degranulation

Manual Curettage PROCEDURE

Degranulation of the extraction socket using a #85 Lucas surgical curette 2.5mm, followed by standardized alveolar ridge preservation with allograft and collagen membrane.

Also known as: #85 Lucas surgical curette, 2.5 mm (CL85, Hu-Friedy Mfg. Co., Chicago, IL, USA)

Manual Curettage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

College of Dentistry, Imam Abdulrahman Bin Faisal University

Dammam, Dammam, 31441, Saudi Arabia

Location

Study Officials

• Marwa Madi

  Departmentof Preventive Dental Sciences, Imam Abdulrahman Bin Faisal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All cone-beam computed tomographic measurements contributing to the analysis are performed by one examiner who is blinded to allocation and who did not perform the surgical procedures. A second examiner, also blinded to allocation and not involved in the surgical procedures, independently measures a predefined subset of scans for reliability assessment only. Patients were not informed of their allocation, but complete patient blinding was not achievable because the rotary handpiece is audible and produces vibration that the curette does not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontics Fellowship Resident

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion: July 9, 2026
• Study Completion (Estimated): January 9, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)