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Buccal Contour Stability at Dental Implant Sites: a Randomized Controlled Clinical Trial Comparing a Ribose Cross-linked Collagen Scaffold with Guided Bone Regeneration

Buccal Contour Stability at Dental Implant Sites: a Randomized Controlled Clinical Trial Comparing a Ribose Cross-linked Collagen Scaffold with Guided Bone Regeneration

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260715002
Enrollment
60
Registered
2026-07-15
Start date
2026-06-09
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deficient buccal bone thickness of 1 to less than 2 millimeters in patients requiring dental implant placement Dental implant Buccal contour Guided bone regeneration Ribose cross-linked collagen scaffold

Interventions

The buccal aspect will be augmented by the Ribose Cross-linked Collagen Scaffold measuring 10*12.5*2 mm (OSSIX Volumax, Datum Dental, Lod, Israel). The scaffold will be placed in double layer (4 mm) t
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Ribose Cross-Linked Collagen Scaffold (RCCS),Guided bone regeneration

Sponsors

Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patients with good systemic health or well-controlled disease, classified as ASA Class I or II. 2. Patients present with a single tooth edentulous area located at posterior region of the maxilla or the mandible. 3. The buccal bone thickness ranges between 1 and 2 mm after implant site preparation. 4. The implant is designed as a bone-level approach. 5. The procedure is a single stage implant surgical protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable or unwilling to comply with the established protocol requirements and schedule. 2. Patients with heavy smoking habits (more than 10 cigarettes per day), or a history of alcoholism 3. Women who are currently pregnant or lactating. 4. Patients who require adjacent dental implants.

Design outcomes

Primary

MeasureTime frame
buccal contour 1, 4-6 month after surgery, 1, 6 month after crown delivery CBCT with intra-oral scan

Secondary

MeasureTime frame
marginal bone loss 1, 4-6 month after surgery, 1, 6 month after crown delivery periapical radiograph,inflammatory and osteogenic biomarkers 1, 4-6 month after surgery, 1, 6 month after crown delivery PICF,peri-implant diagnosis 4-6 month after surgery, 1, 6 month after crown delivery clinical and radiograph parameters,patient reported outcome before surgery, 2 week after surgery, 1, 6 month after crown delivery Oral Health Impact Profile (OHIP-14)

Countries

Thailand

Contacts

Public ContactSupatchaya Tantiwannarath

Faculty of Dentistry, Chulalongkorn University

bell.17290@gmail.com0819455622

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026