Effectiveness of orthodontic mini-implant covers
Not Applicable
Completed
- Conditions
- Oral health (orthodontic)Oral Health
- Registration Number
- ISRCTN93152504
- Lead Sponsor
- niversiti Teknologi MARA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
1. Orthodontic patients requiring MI placement as part of anchorage reinforcement of their orthodontic treatment
2. Age 18 years up to 30 years old
3. Healthy patients with no underlying systemic diseases or illness
4. Requiring posteriorly and buccally placed MI on the maxilla or mandible (distal to the canines)
5. Healthy periodontium and good oral hygiene
Exclusion Criteria
1. Pre-existing oral soft tissue conditions (such as Recurrent Apthous Stomatitis)
2. Previously failed MI or reinsertion of MI
3. On medications that may alter the oral health status
4. Underlying medical conditions such as diabetes
5. Cleft lip and palate patients
6. Smokers
7. Allergies to metals such as stainless steel or titanium
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain score (Numeric Rating Scale) at T0-TD30 at B0 (baseline- before MI insertion for Control group) and T0 (immediately after MI insertion fr SF and CR groups); T1 (1 hour after MI insertion); T12 (12 Hours after MI insertion); T24 (24 hours after MI insertion); TD2 (2 days after MI insertion); TD3 (3 days after MI insertion); TD7 (7 days after MI insertion); TD14 (14days after MI insertion) and TD30 (30 days after MI insertion)
- Secondary Outcome Measures
Name Time Method <br> 1. Oral health-related quality of life using the Modified Short Oral Health Impact profile -14 (at T0 and TD30)<br> 2. Cost-Effectiveness of the MI covers calculated by comparing the current the cost of each material (per syringe) and the amount of MI covers that are produced by a single syringe<br>