Clinical evaluation of 3D printed nano-bioengineered bone graft for alveolar ridge preservation: A randomized controlled trial

Phase 2

Completed

• Conditions: 1.Adult patients (Age > 18 years)2.Good general health (ASA 1, 2) and not contraindication for extraction 3.The diagnosis and indications for extracting tooth are including: endodontic failure; alveolar ridge preservation; guided bone regeneration; bone graft; histomorphometric analysis; marginal bone

• Registration Number: TCTR20181026001
• Lead Sponsor: Faculty of Dentistry Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-26
• Study Completion: 2019-10-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Adult patients (Age > 18 years)
2.Good general health (ASA 1, 2) and not contraindication for extraction
3.The diagnosis and indications for extracting tooth are including: endodontic failure or complications (e.g. root fracture), unable to restore from severe caries or crown/root fracture, hopeless prognosis from periodontitis and for prosthodontics reasons.
4.Controlled periodontitis.
5.Smoking history <10 cigarettes per day. For subject who smokes but less than 10 cigarettes per day is requested to stop smoking two weeks before and after extraction and implant placement.
6.No history of allergy or hypersensitivity to any of the products to be used in the study such as polyethylene.
7.Signed informed consent.
8.Only tooth with an intact buccal bone plate (>50%) and No sign of acute inflammation or infection/abscess. The condition of the buccal bone plate will be evaluated intra-surgically immediately after tooth extraction. All extraction sites must present with a minimum width of 2 mm of keratinized gingival tissue.

Exclusion Criteria

1.Age <18 years.
2.Presence of relevant medical conditions: Patients with bone disease, diabetes mellitus, unstable or life-threatening conditions, or requiring antibiotic prophylaxis. Patients with medication of drugs influencing the bone metabolism or use of bisphosphonates.
3.Smoking status of more than 10 cigarettes/day.
4.Pregnancy or lactation.
5.Patients who cannot take impression (both conventional and digital) and CBCT.
6.Patients who have socket destruction more than 50% after extraction.
7.History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years.
8.History of autoimmune disease or long-term prescribed of steroid drugs.
9.Lack of opposite occluding dentition in the area intended for extraction and subsequent implant placement; absence of adjacent teeth.
10.Presence of dehiscence or fenestration on bone wall of the socket.
11.Unwillingness to return for the follow-up examination

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluation of 3D printed nano-bioengineered bone graft 4month Clinical,Radiogragphic,Histological

Secondary Outcome Measures

Name	Time	Method
dimensional change after tooth extraction with the use of porous polyethylene membrane or commercial 4month Clinical,Radiogragphic,Histological