CompletedNot Applicable

Split Crest Procedure: Is It Necessary to Fill the Gap?

Serbia24 participantsStarted 2024-03-13

Plain-language summary

This prospective controlled clinical study evaluates the effectiveness of adding bone graft or dentin graft material during the split crest (alveolar ridge splitting) procedure for horizontal ridge augmentation with simultaneous implant placement. The study includes patients with narrow alveolar ridges requiring implant-supported rehabilitation. Participants are divided into three groups: split crest without grafting, split crest with bone graft, and split crest with dentin graft. The aim is to determine whether the addition of graft material to the osteotomy gap improves bone width, bone density, and primary implant stability compared to the split crest technique alone. Clinical and radiographic assessments are performed using cone-beam computed tomography (CBCT) and implant stability measurements (ISQ values) before surgery, immediately after implant placement, and three months postoperatively. All patients are monitored over a one-year follow-up period to evaluate healing progression and treatment outcomes. This study seeks to identify the most effective approach for horizontal ridge augmentation and to improve clinical decision-making in implant dentistry. The findings aim to contribute to optimizing surgical protocols, enhancing implant stability, and improving long-term functional outcomes for patients. Participation is voluntary, and all procedures are conducted in accordance with approved ethical standards and clinical guidelines.

Who can participate

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: * Adult patients aged 18-65 years * Indication for tooth extraction in posterior mandibular region with planned implant placement * Presence of post-extraction alveolar bone defect requiring ridge preservation procedure * Good general health (ASA I or ASA II) * Ability to understand the study procedures and provide written informed consent * Willingness to comply with scheduled follow-up visits and study protocol Exclusion Criteria: * Systemic diseases affecting bone healing (e.g. uncontrolled diabetes, osteoporosis, metabolic bone disorders) * History of radiotherapy in the head and neck region * Use of bisphosphonates or other antiresorptive medications * Active periodontal or periapical infection at the surgical site * Heavy smokers (\>10 cigarettes per day) * Pregnancy or breastfeeding * Known allergies to materials used in the study * Poor oral hygiene or lack of complianc

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

Change in alveolar ridge width following split crest proceduree with or without bone or dentin grafting

Timeframe: Preoparative, Immediately postoperative, and 3 months after surgery

Trial details

NCT IDNCT07272694

SponsorVladimir Biocanin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-18

View on ClinicalTrials.gov More Alveolar Bone Resorption trials

Plain-language summary

Who can participate

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.