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
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