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

NCT07330232 | Completed

• 1 other identifier: CEC-SSA 19/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Guided bone regeneration; Horizontal ridge augmentation; Anterior maxilla; Aesthetic zone; Dental implant placement; Periosteal sutures

Outcome Measures

Primary Outcomes (1)

• Mean buccal bone thickness (mm)

  Buccal bone thickness is measured on CBCT at 1 mm, 3 mm, and 6 mm apical to the implant platform (linear distance from implant surface to the outer buccal bone contour). The primary outcome is the mean of these three measurements for each implant.

  6 months

Study Arms (2)

Periosteal mattress sutures for graft/membrane stabilization during GBR with implant placement

EXPERIMENTAL

Guided bone regeneration (GBR) with simultaneous implant placement in the anterior maxilla using a composite xenogeneic collagenated bovine block graft covered by a resorbable collagen membrane. Stabilization is achieved with periosteal mattress sutures to immobilize the graft and membrane, followed by tension-free primary flap closure and standard postoperative care.

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

Titanium tacks for graft/membrane stabilization during GBR with implant placement

ACTIVE COMPARATOR

Guided bone regeneration (GBR) with simultaneous implant placement in the anterior maxilla using a composite xenogeneic collagenated bovine block graft covered by a resorbable collagen membrane. Stabilization is achieved with titanium tacks to fix the graft and membrane, followed by tension-free primary flap closure and standard postoperative care.

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

Interventions

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

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.

Periosteal mattress sutures for graft/membrane stabilization during GBR with implant placement; Titanium tacks for graft/membrane stabilization during GBR with implant placement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seeking implant therapy in the anterior maxilla.
• Patients requiring simultaneous guided bone regeneration (GBR) at the time of implant placement.
• Implant placement performed in a healed ridge (not an immediate post-extraction site).
• Able and willing to provide written informed consent.

You may not qualify if:

• Uncontrolled diabetes.
• Ongoing bisphosphonate therapy.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital San Camilo

San Felipe, Región de Valparaíso, 2172972, Chile

Location

Related Publications (1)

• Moreno X, Neira P, Mandakovic D, Strauss FJ, Cavalla F. Pilot Study: Periosteal Mattress Sutures as an Alternative to Pins and Screws in Guided Bone Regeneration in the Esthetic Zone. Int J Periodontics Restorative Dent. 2023 Oct 24;(7):s217-s226. doi: 10.11607/prd.6212.

  PMID: 37879059 RESULT

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Franco Cavalla, Associate Professor

Model Details: This is a pilot randomized controlled clinical trial with a two-arm, parallel-group (parallel assignment) design. Patients requiring horizontal guided bone regeneration (GBR) with simultaneous implant placement in the anterior maxilla were randomized to one of two graft-stabilization approaches: (1) periosteal mattress sutures (S) or (2) titanium tacks (T). Both groups received the same core surgical intervention (implant placement in healed ridges + horizontal GBR using a xenogeneic composite collagenated bovine block graft covered with a resorbable collagen membrane, followed by tension-free flap closure). The only between-group difference was the fixation method used to stabilize the graft (titanium tacks vs periosteal mattress sutures).

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: December 30, 2021
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)