Periosteal Sutures for Fixation of Composite Bone Graft Substitutes in Guided Bone Regeneration: a Randomized Controlled Clinical Trial
Phase: NA
Conditions: Dental Implants, Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability, Maxillary Alveolar Reconstruction
Sponsor: University of Chile

STUDY PROTOCOL 
 
COVER PAGE 
Official Title: Periosteal Sutures for Fixation of Composite Bone Graft Substitutes in Guided 
Bone Regeneration: A Randomized Controlled Clinical Trial 
NCT Number: NCT[TO BE ASSIGNED] 
Document Type: Study Protocol 
Version/Identifier: Version 1.0 
Document Date: 29-Dec-2025 
Sponsor: SigmaGraft Biomaterials 
Study Site: Periodontics Clinic / Dental Unit, Hospital San Camilo 
Ethics Approval: Scientific Ethics Committee of Servicio de Salud Aconcagua (CEC-SSA 
19/2021) 
 
STUDY PROTOCOL 
 
Title 
Periosteal Sutures for Fixation of Composite Bone Graft Substitutes in Guided Bone 
Regeneration: A Randomized Controlled Clinical Trial 
 
Background and Rationale 
Guided bone regeneration (GBR) performed simultaneously with implant placement is a 
common approach to augment deficient alveolar ridges in the anterior maxilla. Predictable 
outcomes depend on maintaining a stable regenerative compartment and achieving 
tension-free primary closure. Stabilization of the graft and membrane is considered critical 
to limit micromotion during early healing. Titanium fixation devices (tacks) are frequently 
used for this purpose but require additional hardware and procedural steps. Periosteal 
mattress sutures have been proposed as a hardware-free alternative to stabilize the graft 
and membrane through periosteal anchorage. 

 
Objectives 
Primary Objective 
To compare postoperative buccal bone dimensions following horizontal GBR in the anterior 
maxilla using periosteal mattress sutures versus titanium tacks for graft/membrane 
stabilization. 
 
Secondary Objective 
To compare an integrated metric of buccal bone contour (reconstructed buccal bone area) 
derived from CBCT measurements across the evaluated region. 
 
Study Design 
This is a pilot, parallel-arm, randomized controlled clinical trial with two intervention 
groups: 
 
Periosteal mattress sutures for graft/membrane stabilization 
 
Titanium tacks for graft/membrane stabilization 
 
All participants undergo implant placement in healed ridges with simultaneous horizontal 
GBR. The only difference between groups is the stabilization method. 
 
Study Setting 
Participants are recruited consecutively from the Periodontics Clinic / Dental Unit of 
Hospital San Camilo, where patients seeking implant therapy in the anterior maxilla are 
screened for eligibility. 
 
Participant Eligibility 

 
Inclusion Criteria 
 
Patients seeking implant therapy in the anterior maxilla 
 
Clinical indication for simultaneous guided bone regeneration (GBR) at the time of implant 
placement 
 
Implant placement in a healed ridge (not an immediate post-extraction site) 
 
Ability and willingness to provide written informed consent 
 
Exclusion Criteria 
 
Uncontrolled diabetes 
 
Ongoing bisphosphonate therapy 
 
Recruitment and Informed Consent 
Potential participants are screened by the clinical team. A trained investigator not involved 
in surgical treatment provides verbal and written information, obtains written informed 
consent in the presence of an authorized witness, and confirms participation is voluntary 
and can be discontinued at any time. 
 
Randomization and Allocation 
Participants are randomly allocated to one of the two stabilization approaches. 

Randomization method: [Specify method used, e.g., computer-generated random 
sequence] 
Allocation concealment: [Specify method used, e.g., sealed opaque envelopes] 
 
Blinding (Masking) 
Because the stabilization method differs, blinding of the surgeon is not feasible. Clinical 
data collection and radiographic measurements are performed by calibrated personnel not 
involved in the surgical procedures. 
 
Interventions 
 
Common Procedures in Both Arms 
 
Implant placement in healed ridges following standard surgical protocols 
 
Horizontal buccal augmentation using a xenogeneic composite collagenated bovine block 
graft substitute 
 
Coverage with a resorbable collagen membrane 
 
Flap advancement and tension-free primary closure 
 
Standard postoperative care and follow-up 
 
Arm A: Periosteal Mattress Sutures 
The graft and membrane are stabilized using a periosteal mattress suture technique, 
employing vertically oriented periosteal sutures for lateral immobilization and a 

supplemental horizontal mattress suture between flap edges to prevent apical 
displacement. 
 
Arm B: Titanium Tacks 
The graft and membrane are stabilized using titanium fixation tacks to provide rigid 
immobilization. 
 
Schedule of Assessments and Follow-up 
Baseline (after consent) 
 
Full clinical examination 
 
CBCT at an external radiology facility 
 
Digital impressions 
 
Surgery (Day 0) 
 
Implant placement with simultaneous GBR according to allocated stabilization method 
 
Postoperative Follow-up 
 
Day 7: soft tissue healing assessment; suture management as indicated 
 
Day 14: soft tissue healing assessment; suture removal as indicated 
 

Approximately 4 weeks: additional evaluation consistent with institutional implant patient 
protocol 
 
6 months: CBCT and digital impressions for quantitative and qualitative evaluation of 
regenerated tissues 
 
Outcome Measures 
 
Primary Outcome 
Mean buccal bone thickness (mm) at 6 months, 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 endpoint is the mean of the three measurements. 
 
Secondary Outcome 
Reconstructed buccal bone area between 1 mm and 6 mm, calculated from the CBCT-
derived thickness measurements to represent an integrated buccal bone envelope metric. 
 
Radiographic Acquisition and Measurement Procedures 
At 6 months, CBCT is obtained using a standardized acquisition protocol. For each 
implant, measurements are made at 1 mm, 3 mm, and 6 mm apical to the implant 
platform. Cross-sectional views are oriented to obtain a true buccolingual slice 
perpendicular to the implant long axis. Measurements are performed by a calibrated 
examiner using radiographic analysis software with known spatial resolution. 
 
Safety Considerations 
CBCT involves ionizing radiation. Two CBCT scans are performed as part of baseline and 6-
month assessments. Dose-reduction measures are implemented, including use of CBCT 
(instead of conventional CT) and protective lead apron. Clinical follow-up captures healing 
outcomes and any complications. 
 

Data Management and Confidentiality 
Participant information is stored securely with restricted access. Data used for analysis are 
de-identified whenever possible. Only authorized study personnel have access to 
identifiable information. 
 
Ethical Considerations 
The study is conducted under approval of the Scientific Ethics Committee of Servicio de 
Salud Aconcagua (CEC-SSA 19/2021) and in accordance with applicable national 
regulations. Written informed consent is obtained prior to study participation. 
 
Protocol Deviations and Amendments 
Any protocol deviations are documented. Amendments, if required, will be reviewed and 
approved by the ethics committee prior to implementation, unless immediate changes are 
needed to protect participant safety. 
 
Dissemination 
Study findings may be presented at scientific meetings and submitted for publication in 
peer-reviewed journals. No identifying participant information will be disclosed.