Class II Division 1 Malocclusion Clinical Trial
Official title:
Evaluation of Maxillary En-masse Retraction Rate Supported by Mini-screws and Assisted by Traditional or Flapless Corticotomy Techniques: A Randomized Controlled Trial
Verified date | April 2021 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess the dental changes, periodontal health and the pulp vitality in mini-screw supported en-masse retraction associated with traditional or flapless corticotomy techniques. 40 adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study. They will be randomly and equally distributed into two groups: traditional corticotomy (20 patients) versus flapless corticotomy (20 patients). The corticotomy procedure will be performed pre-retraction. The dental changes will be assessed using dental casts. The impressions will be taken after finishing the leveling and alignment phase and before starting the en-masse retraction (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), and 5 months (T5) following the onset of en-masse retraction. The final impression will be considered at the end of the en-masse retraction (when the canines reach Class Ι relationship).
Status | Completed |
Enrollment | 40 |
Est. completion date | October 15, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: 1. Age range between 18 and 30 years. 2. Class II division 1 malocclusion requiring extraction of upper first premolars. 3. Mild to moderate skeletal class II malocclusion. 4. Normal or excessive anterior facial height. 5. No or mild crowding (tooth-size arch-length discrepancy =3 mm). 6. Overjet >5 mm and <10 mm. 7. Completion permanent dentition (regardless of third molars). 8. No previous orthodontic treatment. 9. No drug use or systematic disease that would affect the bone and tooth movement rate. 10. Healthy periodontium and good oral hygiene. Exclusion Criteria: 1. Patients with previous orthodontic treatment. 2. Patients with severe skeletal dysplasia in all three dimensions. 3. Patients suffer from systemic diseases or syndromes 4. Patients on medication for systemic disorders, pregnancy or steroid therapy. 5. Patients showing any signs of active periodontal disease 6. Patients with severe crowding (= 3.5 mm) in maxillary arch 7. Patients with missing or extracted teeth in maxillary arch except third molar. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Department of Orthodontics, University of Damascus Dental School | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20. — View Citation
Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. Epub 2016 Oct 24. Review. — View Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9. — View Citation
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4. — View Citation
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. En-masse Retraction of Upper Anterior Teeth in Adult Patients with Maxillary or Bimaxillary Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. J Contemp Dent Pract. 2019 Jan 1;20(1):113-127. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of en-masse retraction of upper anterior teeth. | The rate of en-masse retraction of upper anterior teeth (mm/month) in each group will be calculated.
This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the upper central incisor edge to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the canine apex and third palatal rugae projections. Measuring the distance (mm) between the central incisor edge and third palatal rugae projections. The rate of en-masse retraction will be measured by dividing the distance between the canine apex/central incisor edge projections and the third palatal rugae projection by the time elapsed between assessment times. |
The calculation of the rate of retraction will be done once the retraction procedures finish. It is expected to happen within 5 months | |
Primary | Change in the anteroposterior movement of the molar at 5 months | The anteroposterior movement of the molar (mm/month) in each group will be calculated.
This outcome will be measured on the dental casts by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The anteroposterior movement of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times. |
T0:1 day before the beginning of the retraction phase. T1: after 1 month of the beginning of retraction phase . T2: after 2 months. T3: after 3 months. T4: after 4 months. T5: immediately after the end of retraction phase (expected to be after 5 months) | |
Primary | Change in the inter-canine width at 5 months | The change in the inter-canine width (mm/month) in each group will be calculated.
Assessment will be performed by measuring the distance between the cusp tips of the two upper canines. This variable will be measured on dental casts. |
T0:1 day before the beginning of the retraction phase. T1: after 1 month of the beginning of retraction phase . T2: after 2 months. T3: after 3 months. T4: after 4 months. T5: immediately after the end of retraction phase (expected to be after 5 months) | |
Primary | Change in the inter-molar width at 5 months | The change in the inter-molar width (mm/month) in each group will be calculated.
Assessment will be performed by measuring the distance between the the central groove of the two first maxillary molars. This variable will be measured on dental casts. |
T0:1 day before the beginning of the retraction phase. T1: after 1 month of the beginning of retraction phase . T2: after 2 months. T3: after 3 months. T4: after 4 months. T5: immediately after the end of retraction phase (expected to be after 5 months) | |
Secondary | The change in dental plaque index according to Silness and Loe | Assessment will be performed using a gingival probe. (0) = No plaque.
= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin which can be seen with the naked eye. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. |
T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months) | |
Secondary | The change in gingival index according to Silness and Loe | Assessment will be performed using a gingival probe. (0) = Normal gingiva.
= Mild inflammation: slight change in color, slight oedema. No bleeding on probing. = Moderate inflammation: redness, oedema and glazing. Bleeding on probing. = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding |
T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months) | |
Secondary | The change in papillary bleeding index according to Muhlemann | Assessment will be performed using a gingival probe. (0) = No bleeding.
= A single discreet bleeding point appears. = Several isolated bleeding points or a single fine line of blood appears. = The interdental triangle fills with blood shortly after probing. = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus. |
T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months) | |
Secondary | The change in gingival recession index according to Miller | The presence of gingival recession on the studied teeth was determined by using a gingival probe and naked eye view, with direct clinical measurement from the cemento-enamel junction to the edge of the free gingiva in the event of the recession. | T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months) | |
Secondary | Tooth vitality | Assessment will be performed from the maxillary right first molar to the maxillary left first molar by using Ethyl chloride spray (endo ice) at a temperature -50°.
Each tooth will be subjected to this ice and the resultant outcome is dichotomous (the tooth is vital, the tooth is not vital). |
T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months) |
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