Abstract

Background Synthetic bone substitutes offer a promising alternative to autografts, allografts, and xenografts for bone tissue regeneration, particularly for lateral bone augmentation (LBA) in the alveolar ridge. Traditional guided bone regeneration techniques for horizontal and vertical ridge defects are complex and associated with higher complication risks. This study introduces a novel in-situ forming scaffold (IFS) that solidifies at the surgery site, providing a stable framework for bone growth. Unlike animal-derived grafts, the IFS scaffold minimizes immunogenicity and disease transmission risks. This trial marks the first-in-human clinical evaluation of a patented IFS following successful preclinical studies. Its safety and efficacy will be assessed in comparison to Bio-Oss Spongiosa through radiographic and histological analyses, offering a novel synthetic approach to bone regeneration.

Methods This randomized, controlled clinical trial will include 37 participants with lateral alveolar bone defects in the anterior region. Participants will be randomized to receive either Bio-Oss Spongiosa or the IFS scaffold. The primary outcomes include the scaffold’s safety and effectiveness in promoting bone regeneration, assessed radiographically and histologically at baseline, postoperatively, and after a 7.5-month healing period. Secondary outcomes involve implant stability and bone formation at re-entry. Blinding will be maintained for participants, outcome assessors, and statisticians.

Discussion This trial represents the first evaluation of an in-situ forming scaffold for LBA. The IFS scaffold is expected to provide outcomes comparable to traditional grafts in bone fill, stability, and implant support, offering a safer synthetic alternative for alveolar bone regeneration. If successful, the findings may significantly advance techniques for alveolar ridge augmentation.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

National Institute for Medical Research Development

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This manuscript describes the study protocol for a randomized controlled trial. The study was approved by the Ethics Committee of the National Institute for Medical Research Development (NIMAD), confirming compliance with national ethical standards. Approval ID: IR.NIMAD.REC.1397.303. Approval Date: July 1, 2018

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

This manuscript describes the study protocol for a randomized controlled trial.

AbbreviationsIRCTIranian Registry of Clinical TrialsIFSIn-situ Forming ScaffoldLBALateral Bone AugmentationGBRGuided Bone RegenerationRCTRandomized Controlled TrialCBCTCone-Beam Computed TomographyRFAResonance Frequency AnalysisISQImplant Stability QuotientOHIP-14Oral Health Impact Profile – 14-itemAEAdverse EventSAESerious Adverse EventITTIntention-to-TreatPPPer-ProtocolPIPrincipal InvestigatorTSCTrial Steering CommitteeDMCData Monitoring CommitteeTUMSTehran University of Medical SciencesNIMADNational Institute for Medical Research DevelopmentCTCAECommon Terminology Criteria for Adverse EventsSAPStatistical Analysis PlanDMPData Management PlanDUAData Use AgreementMSOPManual of Standard Operating ProceduresCRAClinical Research AdministratorRNResearch NurseOMLBACTOutcome Measures in Lateral Bone Augmentation Clinical TrialsSF-12Short Form 12-item General Health QuestionnaireBWSBone Width ScaleBDBone Defect