Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Chitosan Gel Versus Normal Socket Healing In Posterior Maxillary and Mandibular Region

NCT07571863 | Completed DMC

• 1 other identifier: PER 6-3-1 october-2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

After tooth extraction, the alveolar bone, which supports the teeth, undergoes a natural resorption process. This bone loss can be significant, especially in the first few months post-extraction, leading to a reduction in both bone height and width. This resorption can compromise the structural foundation required for future dental restorations, such as implants, bridges, or dentures. Socket preservation technique has been proposed since years as a technique to preserve alveolar bone following extraction and has proved excellent clinical efficacy over years. Several materials have been proposed for alveolar ridge preservation, such as autografts, allografts, xenografts, and alloplasts, each with its own set of advantages and limitations. However, these materials may have limitations, including potential immunogenic responses and variable integration. Thus, there is always a need to explore and validate new materials to mitigate these issues. This study aims to tests one of these new materials named chitosan gel to investigate whether the application of this chitosan gel following posterior mandibular tooth extraction would better preserve alveolar ridge dimensions and improve bone quality compared to normal socket healing or not ?.

Conditions

Alveolar Ridge Preservation; Socket Preservation; Wound Healing

Keywords

chitosan gel

Outcome Measures

Primary Outcomes (1)

• Change in radiographic horizontal ridge width at 3 mm below the most coronal aspect of the crest

  CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point. The horizontal ridge width will be measured at three specific levels: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.

  6 months postoperatively

Secondary Outcomes (4)

• Change in radiographic horizontal ridge width at 1mm and 5mm below the most coronal aspect of the crest.

  6 months postoperatively

• Change in radiographic buccal and palatal ridge height

  at baseline, at 6 months post operatively

• Percentage of new vital bone formation

  6 months postoperatively

• Wound healing and pain

  at baseline,1 day, 5 days, 10 days, 6 months postoperative

Study Arms (2)

Chitogel

EXPERIMENTAL

Chitogel (chitosan gel) for socket preservation

Procedure: Chitosan gel Sigma-Aldrich® in socket preservation

Gelfoam

ACTIVE COMPARATOR

Absorbable gelatin sponge (gelfoam) for socket preservation

Procedure: Gelfoam® absorbable gelatin sponge in socket preservation post extraction

Interventions

Chitosan gel Sigma-Aldrich® in socket preservation PROCEDURE

The interventional group, involves the application of Chitosan gel extract to the extraction socket immediately after tooth extraction. The procedure includes performing the tooth extraction using standard techniques, applying Chitosan gel extract directly into the extraction socket, covering the socket with gelfoam in place, suturing the site stabilized in situ with a Vicryl Plus external criss-cross inverting horizontal mattress suture to ensure stability and containment of the Chitosan gel extract, and following standard postoperative care instructions. Specimen preparation and histomorphometric analysis.

Chitogel

Gelfoam® absorbable gelatin sponge in socket preservation post extraction PROCEDURE

The control group, involves allowing the extraction socket to heal naturally without any additional intervention. The procedure includes performing the tooth extraction using standard techniques, allowing the socket to heal without the application of any grafting materials or membranes, and following standard postoperative care instructions to maintain oral hygiene and manage pain. Postoperative Care and follow up: (Elfana et al., 2021)

Gelfoam

Eligibility Criteria

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

You may qualify if:

• Patient having at least one hopeless tooth in posterior maxillary and mandibular area
• years old or older.
• Motivated patients agree to sign the written informed consent and complete the follow up period
• Medically fit patients.
• No acute infections, pus formation, socket and bony discharges.
• Compliant the patient to ensure the follow up

You may not qualify if:

• Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine).
• Pregnant females.
• Presence of active infection or severe inflammation in the intervention zone.
• Relevant medical history that contraindicates implant surgery.
• Immunosuppression (eg. Hiv, solid-organ transplants).
• Head and neck-irradiated patients in the past 5 years.
• Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
• Chronic drug abuse or alcoholic habits.
• Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score \>15%) and lack of motivation.
• Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%).
• Active periodontal disease.
• Patients with significant comorbidity such as recent heart attack or coagulation disorder.
• Patients with a history of allergies.
• Mentally and physically handicapped patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculaty of Dentistry Cairo University, Cairo, Cairo 35855

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Chitosan Gel Versus Normal Socket Healing In Posterior Maxillary and Mandibular Region. A Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 6, 2026
• Study Start: December 4, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)