The Use of Polycaprolactone Graft to increasing Keratinized Tissue Width before loading Final Prosthesis on Dental Implant: A pilot study

The use of Polycaprolactone Graft to increasing Keratinized Tissue Width before loading Final Prosthesis on Dental Implant: A pilot study

Status

Unknown

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230605005

Enrollment

Registered

2023-06-05

Start date

2023-06-15

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

Healthy patients PCLG

Interventions

Polycaprolactone graft (PCLG) substitution for free gingival graft procedure,Free Gingival Graft (FGG) procedure

Experimental Procedure/Surgery,No Intervention Procedure/Surgery

Polycaprolactone graft (PCLG),Free Gingival Graft (FGG)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (age 18-65 years): males and/or females 2. Good general health (ASA 1, 2) and not a contraindication for minor surgery 3. Patients who needed reconstruction of the posterior edentulous sites of at least one standard implant placement and not exceeded a two-tooth span. 4. Patients with keratinized tissue width on buccal aspect less than 2 mm before loading final prosthesis on dental implant. 5. Smoking history <10 cigarettes per day. For the subject who smokes but less than 10 cigarettes per day is requested to stop smoking two weeks before and after implant placement. 6. No history of allergy or hypersensitivity to any of the materials to be used in the study. 7. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of relevant medical conditions: Patients with uncontrolled diabetes mellitus, unstable or life-threatening conditions, or requiring antibiotic prophylaxis. Patients with medication of drugs influencing the bone metabolism or use of bisphosphonates or denosumabs. 2. Patients with active infection or pathologic lesions prior to operation: Uncontrolled chronic periodontitis 3. Patients who cannot take impression (both conventional and digital) and CBCT 4. Pregnancy or lactation 5. History of malignancy, radiotherapy or chemotherapy for malignancy on the head and neck area 6. Unwillingness to return for the follow-up examination

Design outcomes

Primary

Measure	Time frame
keratinized tissue at 6 months after end of the intervention keratinized tissue width,gingival mucosa at 6 months after end of the intervention thickness of gingival mucosa	—

Secondary

Measure	Time frame
patient satisfaction after surgical procedure visual analog score (VAS)	—

Countries

Thailand

Contacts

Public ContactAthithan Subtanarat

Thammasat University

ct.athithan@gmail.com6625644440

Outcome results

None listed

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