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Periosteal Sutures Versus Titanium Tacks for Guided Bone Re-generation in the Aesthetic Zone: a Pilot Randomized Controlled Trial

NCT07330232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-09

No results posted yet for this study

Summary

This randomized controlled clinical study, titled "Periosteal sutures for fixation of composite bone substitutes in guided bone regeneration: a randomized controlled clinical study," is being conducted at the Dental Unit of Hospital San Camilo and is sponsored/funded by SigmaGraft Biomaterials.

Purpose: The purpose of this study is to evaluate whether using a periosteal stabilization suturing technique improves outcomes in guided bone regeneration in the anterior maxilla when a composite bone graft substitute is used in conjunction with dental implant installation.

What participation involves: Participants will undergo clinical assessments and data collection by the research team according to the study protocol. As part of study-related imaging, participants will receive two cone-beam computed tomography (CBCT) scans, which involve exposure to ionizing radiation. To reduce radiation exposure, CBCT imaging will be performed at a private imaging center rather than using a conventional hospital CT scanner, and participants will use a lead apron for additional protection.

Potential benefits and risks: No direct benefit is expected for participants. However, the information gained may help improve future treatment approaches for patients requiring dental implants in the anterior maxilla with associated bone grafting procedures. The main risks described relate to exposure to ionizing radiation from CBCT imaging, and measures are in place to minimize this exposure.

Privacy and voluntary participation: Participant confidentiality will be protected. Study information will be stored securely with restricted access, and analyses will use de-identified data. Participation is voluntary, and participants may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled.

Conditions

  • Dental Implants
  • Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability
  • Maxillary Alveolar Reconstruction

Interventions

PROCEDURE

Periosteal mattress sutures for graft/membrane stabilization in guided bone regeneration Titanium tacks for graft/membrane stabilization in guided bone regeneration

Periosteal mattress sutures: Hardware-free stabilization of the graft and collagen membrane using periosteal anchorage sutures to limit micromotion during guided bone regeneration with simultaneous implant placement in the anterior maxilla. Titanium tacks: Hardware-based stabilization of the graft and collagen membrane using titanium fixation tacks to achieve rigid immobilization during guided bone regeneration with simultaneous implant placement in the anterior maxilla.

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2024-07-30
Completion
2024-12-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330232 on ClinicalTrials.gov