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
- Conditions
- Residual bone height 5 to 8 mm.Volunteers who have lost a single upper premolar or molar tooth for 3 or more months with adequate bone width (6mm or more) and 5-8 mm of residual alveolar bone height
- Registration Number
- TCTR20210517008
- Lead Sponsor
- Center of Excellence for Dental Implantology, Faculty of Dentistry, Chiang Mai University, Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method implant stability immediate after implant placement or 3 months after placement and every 3 months until 1 years and 3 months after implantation. Resonance frequency analysis
- Secondary Outcome Measures
Name Time Method success, survival or failure rate 6 months and 1 year after crown insertion mobility, bone loss in radiography, exudates history, pain, ability to stay in the patient's mouth,endo sinus bone gain and marginal bone loss immediate after implant placement or 3 months after placement and every 3 months until 1 years and 3 months after implantation. millimetre in radiography