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Clinical Trials/TCTR20210517008
TCTR20210517008Active, not recruitingPhase 4

Implant Stability and Clinical Outcome between Implant Placement Using Internal Sinus Floor Elevation with Alloplastic Bone Material Grafting and Without Grafting: A Randomized Clinical Trial Comparative Study

Center of Excellence for Dental Implantology, Faculty of Dentistry, Chiang Mai University, Thailand0 sites30 target enrollmentStarted: May 17, 2021Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Sponsor
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
20 Years to 68 Years (—)
Sex
All

Inclusion Criteria

  • 1.Healthy volunteers ages, 20-68years
  • 2.Single loss of premolar or molar in the posterior maxilla which is extracted at least 3 months with normal wound healing
  • 3.A residual bone height of 5-8 mm with adequate bone width of 6 mm or above
  • 4.Good intra-oral soft and hard tissue condition with adequate surrounding keratinized mucosa (at least 4 mm) from gingival margin of the tooth.
  • 5.Good condition of the nearby and opposing tooth
  • 6.No smoking or smoking less than 10 cigarettes/day in the last 5 years
  • 7. Patient can clean and maintain the prosthesis and oral health regularly
  • 8. No history of psychosis
  • 9.No use of any medications that could influence bone remodeling including bisphosphonates and antiangiogenic drugs via intravenous injection in the past 5 years
  • 10.Able and agree to undergo treatment and follow-up for a total of 12-14 visits
  • 11.Understand research procedure with informed consent for participation in the clinical trial
  • 12. No problem of temporomandibular joint disorder or any disease that will involve the quality of mastication

Exclusion Criteria

  • 1.Have Bleeding disorder, or uncontrolled systemic disease, ASA class III
  • 2. Presence of bone pathologies such as cyst or tumor
  • 3.Uncontrolled periodontal disease with a periodontal pocket of more than 4 mm in adjacent teeth and opposite tooth
  • 4. Poor oral hygiene needs further treatment before implantation such as periodontal therapy
  • 5.Have had radiotherapy to the head or neck
  • 6.Drug or alcohol abuse such as steroid, antibiotics
  • 7.Pregnant woman, nursing mother, or lactation
  • 8.Acute/chronic paranasal sinusitis or rhinitis
  • 9.previous bone graft or implant placement in the posterior maxilla
  • 10.Demonstrate negative attitude towards implants and prosthesis
  • 11.Unable to participate until the study is complete

Investigators

Sponsor
Center of Excellence for Dental Implantology, Faculty of Dentistry, Chiang Mai University, Thailand

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