Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Chitosa… (NCT07571863) | Clinical Trial Compass
CompletedNot Applicable
Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Chitosan Gel Versus Normal Socket Healing In Posterior Maxillary and Mandibular Region
Egypt26 participantsStarted 2024-12-04
Plain-language 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 ?.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient having at least one hopeless tooth in posterior maxillary and mandibular area
* 18 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in radiographic horizontal ridge width at 3 mm below the most coronal aspect of the crest