Clinical efficacy of polycaprolactone membrane for bone augmentation in dental implant treatment: Pilot study

Phase 2

Completed

• Conditions: Adult patients (Aged 20-65 years)Good general health (ASA 1, 2) and not a contraindication for minor surgeryThe diagnosis and indications for guided bone regeneration; Dental implants, Guided bone regeneration

• Registration Number: TCTR20200526010
• Lead Sponsor: Faculty of Dentistry, Thammasat University

Brief Summary

The augmented alveolar ridge was evidently successful in both groups while slightly resorbed at 6-months follow-up. Minimal loss of STC was observed in both groups up to 1 year of loading. No statistically significant difference was found between the two groups in all assessed outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-26
• Study Completion: 2022-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1.Adult patients (age 20-70 years)
2.Good general health (ASA 1, 2) and not a contraindication for minor surgery
3.The diagnosis and indications for a particulate bone substitute include:
a.Alveolar bone defects, class 2 (Benic & Hammerle 2014).
b.The edentulous area allows placement of at least one standard implant and not exceed a two-tooth span.
4.Patients who needed reconstruction of the edentulous sites with simultaneous implant placement
5.Controlled periodontitis.
6.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 bone block graft surgery and implant placement
7.No history of allergy or hypersensitivity to any materials to be used in the study.
8.Signed informed consent.

Exclusion Criteria

1.Presence of relevant medical conditions: Patients with bone disease, osteoporosis, 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.
2.Pregnancy or lactation.
3.Patients who have poor oral hygiene.
4.Patients with active infection or pathologic lesions prior to operation
5.Patients who cannot take impression (both conventional and digital) and CBCT
6.History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years.
7.History of autoimmune disease or long-term prescribed of nonsteroidal anti-inflammatory drugs
8.Unwillingness to return for the follow-up examination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone thickness and soft tissue dimensional change 1 year after loading Clinical,Radiogragphic

Secondary Outcome Measures

Name	Time	Method
Clinical parameters, marginal bone level, Implant stability, wound healing, esthetic score 1 year after loading Radiographic