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Clinical Trials/TCTR20180913001
TCTR20180913001
Completed
Phase 2

Clinical efficacy of porous polyethylene membrane for ridge preservation: A pilot study

Faculty of Dentistry Thammasat University0 sites30 target enrollmentSeptember 13, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
1.Adult patients (Age > 18 years)2.Good general health (ASA 1&#44
Sponsor
Faculty of Dentistry Thammasat University
Enrollment
30
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 13, 2018
End Date
January 1, 2020
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Faculty of Dentistry Thammasat University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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