Clinical trial
Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles (A Randomized Clinical Trial)
Name
Coated Orthodontic Miniscrews
Description
Aim To compare between orthodontic miniscrews coated and uncoated with CHX- HMP NP nanoparticles.
Trial arms
Trial start
2023-02-10
Estimated PCD
2023-11-12
Trial end
2023-12-20
Status
Completed
Phase
Early phase I
Treatment
Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles
insertion:
1. According to the random number generated, the corresponding envelop for left and right side by chosen.
2. The patient will be asked to brush his/her teeth.
3. The patient will rinse his/her mouth with chlorhexidine mouth rinse (0.12%) just before surgery being at least half an hour after brushing.
The miniscrews used conical shaped, self-drilling, 1.6 mm in diameter, 8mm in length made of Ti.
1. The site of insertion determined from the x-ray by using stent that will be fabricated for accurate site for OMS.
2. Infiltration LA will be administered. Approximately 0.45 mL ,injected into the alveolar mucosa above the OMS placement site, in order to provides an acceptable anesthesia, while still allowing the patient feedback in case the OMS contacting the periodontal ligament (PDL).
3. OMS will be placed manually by screw driver on buccally at an angle 90 degrees and then adjusted to the appropriate angle.
4. x-ray will be taken to confirm OMS position.
Arms:
Coated Miniscrew
Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles
Non-coated orthodontic miniscrews
Arms:
Uncoated Miniscrew
Size
39
Primary endpoint
Compare the success rate of coated and uncoated miniscrews.
for 4 month.
Eligibility criteria
Inclusion Criteria:
* Undergoing orthodontic treatment by fixed orthodontic appliance.
* Indicated for a bilateral miniscrews.
* Good oral hygiene.
Exclusion Criteria:
* Medically compromised patients.
* Heavy smoker.
* Dry mouth ( Xerostomia).
* mucogingival lesions.
* Patients with chlorhexidine allergy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 39, 'type': 'ACTUAL'}}
Updated at
2023-12-29
1 organization
2 products
1 indication
Organization
University of BaghdadIndication
Orthodontic Appliance Complication