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Randomized controlled pilot study on the application of three dimensional printed polycaprolactone biphasic calcium phosphate scaffold for alveolar ridge preservation

Randomized controlled pilot study on the application of three dimensional printed polycaprolactone biphasic calcium phosphate scaffold for alveolar ridge preservation

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231107005
Enrollment
15
Registered
2023-11-07
Start date
2023-02-23
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

Alveolar ridge deficiency Dimensional changes following an extraction Scaffold, Polymer, Ceramic, Polycaprolactone, Biphasic calcium phosphate, Alveolar ridge preservation

Interventions

After tooth extraction, the PCL-30%BCP TDP scaffolds were filled into the sockets at the level of 1 mm below the crests of the socket walls.,After tooth extraction, the pure PCL scaffolds were filled
Experimental Device,Sham Comparator Device,No Intervention No treatment
The PCL-30%BCP TDP scaffolds,The Pure PCL scaffold scaffolds,The empty socket

Sponsors

Faculty of Dentistry Prince of Songkla University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Healthy adult patients at least 20 years old (but no more than 65 years old), American Society of Anesthesiology (ASA) classification I-II. 2. The patients who planned for extracting un-restorable premolar or molar teeth followed with implant placement. Socket defect type in Elian classification I, IIa and IIb. 3. No severe periapical infection of extraction sites. 4. Patients are willing to participate and follow the study protocol.

Exclusion criteria

Exclusion criteria: 1. The patient who has a severe periapical infection at extraction sites. 2. The patient with systemic diseases consists of uncontrolled DM, bleeding disorder, immunodeficiency, smoking habit, previous radiotherapy, or chemotherapy, and long-term taking bisphosphonate or steroid. 3. The patient is unable to follow the study protocol.

Design outcomes

Primary

MeasureTime frame
The dimensional changes of the alveolar ridge 5 Months Radiographic evaluation (CBCT images)

Secondary

MeasureTime frame
Alveolar ridge volume changes 5 Months Volumetric analysis tool,The new bone formation 5 Months Histological analysis,Stability of dental implant 3 Months Implant Stability Quotient; ISQ

Countries

Thailand

Contacts

Public ContactNattawut Thuaksubun

Faculty of Dentistry Prince of Songkla University

nuttawut.t@psu.ac.th0954592492

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026