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

Phase 2

• Conditions: PCLG; Healthy patients

• Registration Number: TCTR20230605005
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-05
• Study Completion: 2024-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
patient satisfaction after surgical procedure visual analog score (VAS)