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

November 26, 2025 updated by: Vladimir Biocanin

A Prospective Controlled Clinical Study Evaluating the Effect of Bone and Autologous Dentin Grafting in the Osteotomy Gap During the Split Crest Procedure With Simultaneous Implant Placement

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pančevo, Serbia, 26000
        • Faculty of Stomatology, Department of Oral Surgery, University Business Academy in Novi Sad,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Split Crest Only
A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement. A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.
Experimental: Split Crest + Bone Graft
A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement. A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.
Experimental: Split Crest + Dentin Graft
A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement. A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in alveolar ridge width following split crest proceduree with or without bone or dentin grafting
Time Frame: Preoparative, Immediately postoperative, and 3 months after surgery
Preoparative, Immediately postoperative, and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Actual)

June 18, 2024

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SC-DENTIN-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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