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.

Tooth extraction is one of the most common procedures in dental practice, initiating a complex healing process within the socket. A critical step for uneventful healing is the complete removal of chronic granulation tissue, which is often present due to pre-existing periapical or periodontal pathology, retained granulation tissue can impede proper bone regeneration and contribute to postoperative complications.

1.1 Study Design: A prospective, case-controlled, randomized clinical trial conducted in accordance with CONSORT guidelines.

This study introduces an objective endpoint to this comparison by utilizing Toluidine Blue (TB), a vital stain that selectively binds to acidic tissue components like DNA and RNA, which are abundant in dysplastic and highly cellular tissues like granulation tissue. By employing TB staining immediately after the surgeon's subjective assessment of a clean socket, this study aims to provide a visual, objective measure of the thoroughness of each technique in addition to cone-beam computed tomography (CBCT) granulation tissue volume measurement.

Furthermore, the rationale for thorough degranulation extends beyond facilitating uneventful healing and is a critical determinant for the success of subsequent restorative procedures, particularly alveolar ridge preservation (ARP) and dental implant placement. Retained chronic granulation tissue can act as a physical and biological barrier, impeding the migration and proliferation of osteogenic cells and the integration of bone graft materials. This compromised graft incorporation can lead to suboptimal bone quality and volume, ultimately undermining the primary goal of ARP to minimize post-extraction ridge atrophy. Moreover, the presence of inflamed, non-mineralized tissue at the future implant site has been linked to higher failure rates, as it prevents the direct bone-to-implant contact osseointegration essential for long-term stability. Therefore, establishing a clean, well-prepared bony socket is not merely a procedural step, but a fundamental prerequisite to creating a predictable environment for successful bone grafting and, ultimately, the placement of a functional dental implant. While ARP studies focus on grafting materials and membranes, little attention has been given to the effect of degranulation technique itself.

Rationale:

Although alveolar ridge preservation (ARP) procedures have been widely investigated with a focus on grafting materials and membrane types, the influence of the degranulation technique, a critical preliminary step in socket healing has received little scientific attention. Incomplete removal of inflamed or necrotic granulation tissue may hinder bone regeneration, compromise graft integration, and increase the risk of postoperative complications. Conversely, achieving a clean, viable bony socket can enhance the healing environment and improve both soft and hard tissue outcomes. This study proposes that the method of degranulation, whether manual or rotary, may significantly influence healing outcomes by affecting the thoroughness of socket cleaning, operative time, and the subsequent bone preservation process. The use of Toluidine Blue (TB) staining provides an objective and reproducible endpoint for assessing socket cleanliness, while CBCT-based volumetric analysis (Cone-Beam Computed Tomographic Periapical Volume Index, CBCTPAVI) enables quantitative evaluation of lesion resolution and bone healing.

Hypothesis:

It is hypothesized that rotary degranulation using mechanical burs will result in more efficient and complete removal of granulation tissue, as evidenced by shorter operative times, higher rates of TB-confirmed clean sockets, and improved clinical and radiographic healing outcomes including alveolar ridge preservation when compared with traditional manual curettage.

1.3 Groups: Intervention Group (n = 26): Granulation tissue removed with a 2.5mm super coarse diamond bur.

Control Group (n = 26): Granulation tissue removed with a #85 Lucas surgical curette 2.5mm.

Standardized Procedure: A single surgeon will perform all procedures using 2.5x loupes and a shadow-less headlight to ensure a consistent endpoint.

Pre-operative Volumetric Assessment: Pre-operative volumetric assessment of the roots within alveolar bone and the periapical lesion will be performed using CBCT, a validated tool for such diagnostics, and calculated using ITK-SNAP software. The resulting volume in cubic millimeters (mm³) will then be used to classify each lesion according to the Cone-Beam Computed Tomographic Periapical Volume Index (CBCTPAVI). This volumetric classification will provide a standardized baseline measure of the initial pathology and socket volume.

Intervention Protocol:

2.1 Tooth Extraction: Atraumatic extraction will be performed for all teeth using minimal flap reflection and tooth sectioning as needed.

2.2 Randomization: Patients will be randomly assigned in a 1:1 ratio using a computer-generated block randomization schedule with randomly varying block sizes to ensure balanced group numbers throughout the trial (Sealed envelope™). Allocation will be concealed using sequentially numbered, opaque, sealed envelopes (SNOSE) opened after extraction.

2.3 Staining Phase: To provide an objective endpoint, the socket will be stained with 1% Toluidine Blue, a vital stain that binds to tissues with high cellular turnover, such as granulation tissue. Intra-oral digital photograph will be taken immediately after the extraction.

Saline irrigation of the extraction socket for 20 seconds.

Apply 1% Toluidine Blue using micro brush to the socket walls and the granulation tissue for 1 minute.

Rinse for 1 minute with Saline to remove excess stain.

2.4 Degranulation Phase:

Intra-oral digital photographs will be taken immediately after the socket staining. A digital timer, operated by a second assistant, will be started when the instrument first engages the socket.

Test Group: Degranulation will be performed using a 2.5mm degranulation burs (super coarse diamond burs) at 1000-1200 revolutions per minute (RPM) speed.

Control Group: Degranulation will be performed using #85 Lucas surgical curette 2.5mm.

The timer will be stopped when the surgeon verbally declares the socket visually clean. This is recorded as the Primary Outcome (Time in seconds).

The surgeon will continue debridement until the socket is visually and tactilely free of granulation tissue and achieves a 'stain-free' endpoint as confirmed by Toluidine Blue staining. Both instruments provide adequate tactile feedback to assess socket cleanliness.

2.5 Alveolar Ridge Preservation Phase: Following debridement, all sockets will undergo standardized alveolar ridge preservation with an allograft and collagen membrane, a procedure demonstrated to mitigate post-extraction bone loss.

Post-operative Care: All patients will receive standardized postoperative instructions. Administer Amoxicillin 500 mg every 8 hours for 5-7 days and Ibuprofen 400-600 mg every 6-8 hours as needed for pain.

3.1 Outcome Measure: Primary: Operation Time Outcome assessors (photographs/CBCT analysis) will be blinded to the intervention group to reduce bias. The primary outcome of operative time was selected as a key metric for clinical efficiency as outlined in a recent scoping review.

The 2nd assistant will record the time (seconds) from instrument engagement until the surgeon declares the socket clinically stain-free and without any soft tissue.

Secondary:

Toluidine Blue "stain-free" endpoint (% of sockets)

CBCT-measured socket volume reduction after 3-6 months

Patient-reported outcome measures (pain visual analog scale [VAS], swelling)

Postoperative complications (infection, delayed healing, membrane exposure, graft loss)

Statistical Analysis:

All analyses will be two-sided with α = 0.05 and 95% confidence intervals (CIs). The primary outcome (operative time in seconds) will be compared between the rotary-bur and manual-curette groups using analysis of covariance (ANCOVA) with pre-operative CBCT lesion volume (mm³) entered as a covariate to increase precision and adjust for baseline pathology burden. Model assumptions (linearity of covariate effect, homoscedasticity, normality of residuals) will be evaluated via residual diagnostics; if serious deviations persist after transformation, a rank-ANCOVA sensitivity analysis will be performed.

Secondary outcomes:

Stain-free socket after first debridement cycle (yes/no): compared using logistic regression with group as the main effect and baseline lesion volume as a covariate; results reported as odds ratios with 95% CIs. CBCT ridge dimensional changes (e.g., vertical/horizontal bone change) at follow-up: analyzed with a linear mixed-effects model (time as a within-subject factor, group as a between-subject factor, group × time interaction). Baseline dimension entered as a covariate; participant will be a random intercept if more than one timepoint per participant. Patient-reported pain (VAS) at post-op days 1-7: assessed using a linear mixed-effects model (or Mann-Whitney U at a single timepoint if only one assessment), adjusting for baseline analgesic intake if collected.

Early complications (e.g., infection, membrane exposure): compared with chi-square/Fisher's exact; if timing is recorded, time-to-event curves (Kaplan-Meier) with log-rank test will be added exploratorily.

Where applicable, we will report effect sizes (mean difference, adjusted mean difference, odds ratio, or standardized effects) with 95% CIs. Analyses will follow intention-to-treat (ITT) principles; a per-protocol analysis excluding major protocol deviations will be provided as sensitivity. Missing outcome data will be minimized through follow-up; if >5% is missing, multiple imputations by chained equations will be used under a missing-at-random assumption. If more than one tooth per participant is enrolled, clustering will be addressed by including participant as a random effect (mixed models) or by using cluster-robust standard errors (ANCOVA/logistic). All statistical analyses will be performed using IBM SPSS Statistics, version 27.0 or higher (IBM Corp., Armonk, NY, USA).

Inclusion Criteria:

• 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.
• 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.
• Uncontrolled systemic diseases (e.g., diabetes, immunocompromised status).
• 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.

There is no plan to make individual participant data (IPD) available to other researchers due to institutional privacy policies.