Micro-osteoperforations and Tooth Movement

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02473471
• Date of registration: 16/04/2015
• Prospective Registration: No
• Primary sponsor: Jordan University of Science and Technology
• Public title: Micro-osteoperforations and Tooth Movement
• Scientific title: Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
• Date of first enrolment: April 2015
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02473471
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Jordan

Contacts

• Name: Emad Al Maaitah, Ph.D.
• Affiliation: Jordan University of Science and Technology

• Name: Elham S. Abu Alhaija, Ph.D
• Affiliation: Jordan University of Science and Technology

• Name: Hisham Alshorman, Ph.D.
• Affiliation: Jordan University of Science and Technology

• Name: Amal A Alkebsi, MClinDent
• Affiliation: Jordan University of Science and Technology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female

- between 16 to 26 years old

- Class II Division 1 malocclusion or bimaxillary protrusion

- Average Lower facial height and Mandibular plane angle

- No systemic disease

- Healthy periodontal condition

- Non smoker

- Probing depth less than 4 mm in all teeth

Exclusion Criteria:

- Long-term use of any Medication

- Poor oral hygiene

- Low and high angle cases

- Systemic disease

- Evidence of bone loss

- Active periodontal disease

- Smoker

- Probing depth more than 4 mm in all teeth

Cephalometric analysis of the included subjects was performed at baseline including

1. Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA)
indicates the horizontal position of the maxilla relative to the cranial base.

2. Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the
horizontal position of the mandible relative to the cranial base.

3. A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal
relationship between the maxilla and mandible.

4. Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane
and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the
anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a
line through the gonion and menton.

5. Lower anterior facial height(LAFH)

6. Upper incisor inclination: The angle between the maxillary plane and the axis of the
maxillary incisors.



Age minimum: 16 Years
Age maximum: 26 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malocclusion

Intervention(s)

Device: Micro-osteoperforation

Primary Outcome(s)

3D Digital Model Measurements of Canine Rate of Tooth Movement [Time Frame: Baseline to 2nd month]

3D Digital Model Measurements of Canine Rate of Tooth Movement [Time Frame: Baseline to 1st month]

Intra Oral Measurements of Canine Rate of Tooth Movement [Time Frame: Baseline to 2nd month]

3D Digital Model Measurements of Canine Rate of Tooth Movement [Time Frame: Baseline to 3rd month]

Intra Oral Measurements of Canine Rate of Tooth Movement [Time Frame: Baseline to 3 month]

Intra Oral Measurements of Canine Rate of Tooth Movement [Time Frame: Baseline to 1st month]

Secondary Outcome(s)

Pain Interference /Pain During Eating? [Time Frame: within 7 days after the intervention]

Pain Intensity [Time Frame: within 7 days after the intervention]

Pain Interference /Pain Interrupted Sleep [Time Frame: within 7 days after the intervention]

Pain Interference /Swelling of the Surgical Side [Time Frame: within 7 days after the intervention]

Root Resorption [Time Frame: Baseline to 3rd month]

Menstrual Cycle [Time Frame: within 3 months]

Pain Interference /Discomfort [Time Frame: within 7 days after the intervention]

Patient Satisfaction [Time Frame: After 7 days of MOP application]

Secondary ID(s)

JordanUST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02473471