Class II Division 1 MalocclusionNCT04847492
Evaluation of Upper Anterior Teeth Retraction Rate Assisted by Two Corticotomy Techniques
A study testing Traditional corticotomy and Flapless corticotomy in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Traditional corticotomy and Flapless corticotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 9 Jun 2017to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 18 and 30 years.
- Class II division 1 malocclusion requiring extraction of upper first premolars.
- Mild to moderate skeletal class II malocclusion.
- Normal or excessive anterior facial height.
- No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
- Overjet >5 mm and <10 mm.
Show all 10Show fewer
- Completion permanent dentition (regardless of third molars).
- No previous orthodontic treatment.
- No drug use or systematic disease that would affect the bone and tooth movement rate.
- Healthy periodontium and good oral hygiene.
Who cannot join
- Patients with previous orthodontic treatment.
- Patients with severe skeletal dysplasia in all three dimensions.
- Patients suffer from systemic diseases or syndromes
- Patients on medication for systemic disorders, pregnancy or steroid therapy.
- Patients showing any signs of active periodontal disease
- Patients with severe crowding (≥ 3.5 mm) in maxillary arch
- Patients with missing or extracted teeth in maxillary arch except third molar.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus
About this study
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
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).
Read the detailed description
One of the most important challenges in daily practice is prolonged orthodontic treatment duration. For that lots of therapeutic procedures have been introduced to minimize orthodontic treatment time such as surgical interventions. Even though the traditional corticotomy with flap elevation proved to be effective in accelerating different types of tooth movement, it has been deemed aggressive. Therefore, minimally invasive surgical techniques have been proposed and labeled 'flapless corticotomies'.
In flapless corticotomy group, vertical soft-tissue incisions will be made on the buccal and palatal gingiva by using a blade N.15. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and second premolars. The incisions will be 5 mm long and started 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8-mm in length. No suturing will be needed.
In traditional corticotomy group, a full-thickness mucoperiosteal flap will be elevated including the interdental papilla, and extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. The full-thickness flap will be extended 3 mm above the root apices, from the buccal and palatal sides, knowing that the incision in the incisal papilla region will be done around it with a (V) or (U) shape. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife. The vertical incisions will be connected by a horizontal incision using the piezosurgery knives. The vertical incisions will be 3 mm in depth, starting 2-3 mm apical to the alveolar crest, and extending 3 mm beyond the root apices. The interrupted technique of suturing will be done using a non-absorbent 3-0 black silk.
The en-masse retraction will be begun 4 days after carrying out the corticotomy procedure using 0.019×0.025-inch SS archwires with 8-10-mm long soldered hooks located distal to the lateral incisors. NiTi closed coil springs with 9-mm long will be extended from the mini-screws to the soldered hooks and applied 250-g of force per side. The patients' follow-up appointments will be every 2 weeks. The force will be measured on every appointment and adjusted if needed. The endpoint of the monitoring period will be the session when canines reached a class Ι relationship.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Traditional corticotomy, Flapless corticotomy
- Keywords
- En-masse, retraction, corticotomy, flapless, miniscrew, upper anterior teeth
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional corticotomyProcedure or surgery
A full-thickness mucoperiosteal flap will be elevated including the interdental papilla, and extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife.
Flapless corticotomyProcedure or surgery
Vertical soft-tissue incisions will be made on the buccal and palatal gingiva by using a blade N.15. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars.
| Study group | Role | What they receive |
|---|---|---|
| Traditional corticotomy | Active comparator | Adult patients will be treated by en-masse retraction associated with traditional corticotomy. Receives: Procedure: Traditional corticotomy |
| Flapless corticotomy | Experimental | Adult patients will be treated by en-masse retraction associated with flapless corticotomy. Receives: Procedure: Flapless corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The calculation of the rate of retraction will be done once the retraction procedures finish. It is expected to happen within 5 months
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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 outcomes (5)
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.
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start9 Jun 2017
- Primary completion1 Jan 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanin Nizar Khlef, DDS,MSc, Principal investigator, Specialist and Clinical Lecturer, Department of Orthodontics, University of DamascusMohammad Y Hajeer, DDS,MSc,PhD, Study chair, Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, SyriaOmar Heshmeh, DDS,MSc,PhD, Study director, Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847492
- Sponsor's protocol ID
- UDDS-Ortho-03-2021
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23787192Khlef 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.
PubMed 31058623Alfawal 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. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
PubMed 27696311Alfawal 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.
PubMed 29454369Khlef 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.
PubMed 33158633Khlef HN, Hajeer MY. Is It Possible to Achieve Favorable Accelerated Dental Changes with No Periodontal Complications When Retracting Upper Anterior Teeth Assisted by Flapless Corticotomy Compared to Traditional Corticotomy? A Two-Arm Randomized Controlled Trial. ScientificWorldJournal. 2022 Mar 7;2022:4261248. doi: 10.1155/2022/4261248. eCollection 2022.
PubMed 35295761
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04847492
- Acronym / sponsor ID
- UDDS-Ortho-03-2021
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- En-masse, retraction, corticotomy, flapless, miniscrew, upper anterior teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
One of the most important challenges in daily practice is prolonged orthodontic treatment duration. For that lots of therapeutic procedures have been introduced to minimize orthodontic treatment time such as surgical interventions. Even though the traditional corticotomy with flap elevation proved to be effective in accelerating different types of tooth movement, it has been deemed aggressive. Therefore, minimally invasive surgical techniques have been proposed and labeled 'flapless corticotomies'.
In flapless corticotomy group, vertical soft-tissue incisions will be made on the buccal and palatal gingiva by using a blade N.15. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and second premolars. The incisions will be 5 mm long and started 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8-mm in length. No suturing will be needed.
In traditional corticotomy group, a full-thickness mucoperiosteal flap will be elevated including the interdental papilla, and extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. The full-thickness flap will be extended 3 mm above the root apices, from the buccal and palatal sides, knowing that the incision in the incisal papilla region will be done around it with a (V) or (U) shape. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife. The vertical incisions will be connected by a horizontal incision using the piezosurgery knives. The vertical incisions will be 3 mm in depth, starting 2-3 mm apical to the alveolar crest, and extending 3 mm beyond the root apices. The interrupted technique of suturing will be done using a non-absorbent 3-0 black silk.
The en-masse retraction will be begun 4 days after carrying out the corticotomy procedure using 0.019×0.025-inch SS archwires with 8-10-mm long soldered hooks located distal to the lateral incisors. NiTi closed coil springs with 9-mm long will be extended from the mini-screws to the soldered hooks and applied 250-g of force per side. The patients' follow-up appointments will be every 2 weeks. The force will be measured on every appointment and adjusted if needed. The endpoint of the monitoring period will be the session when canines reached a class Ι relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional corticotomy | Active comparator | Procedure: Traditional corticotomyAdult patients will be treated by en-masse retraction associated with traditional corticotomy. |
| Flapless corticotomy | Experimental | Procedure: Flapless corticotomyAdult patients will be treated by en-masse retraction associated with flapless corticotomy. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age range between 18 and 30 years.
- Class II division 1 malocclusion requiring extraction of upper first premolars.
- Mild to moderate skeletal class II malocclusion.
- Normal or excessive anterior facial height.
- No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
Key exclusion criteria (7 listed)
- Patients with previous orthodontic treatment.
- Patients with severe skeletal dysplasia in all three dimensions.
- Patients suffer from systemic diseases or syndromes
- Patients on medication for systemic disorders, pregnancy or steroid therapy.
- Patients showing any signs of active periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional corticotomyA full-thickness mucoperiosteal flap will be elevated including the interdental papilla, and extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife. | Procedure or surgery | Traditional corticotomy |
| Flapless corticotomyVertical soft-tissue incisions will be made on the buccal and palatal gingiva by using a blade N.15. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. | Procedure or surgery | Flapless corticotomy |
Primary outcome
The rate of en-masse retraction of upper anterior teeth.
Time frame: The calculation of the rate of retraction will be done once the retraction procedures finish. It is expected to happen within 5 months
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.
Change in the anteroposterior movement of the molar at 5 months
Time frame: 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)
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.
Change in the inter-canine width at 5 months
Time frame: 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)
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.
Change in the inter-molar width at 5 months
Time frame: 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)
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.
5 secondary outcomes
The change in dental plaque index according to Silness and Loe
Time frame: 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)
The change in gingival index according to Silness and Loe
Time frame: 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)
The change in papillary bleeding index according to Muhlemann
Time frame: 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)
The change in gingival recession index according to Miller
Time frame: 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)
Tooth vitality
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Background: PubMed 23787192Al-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.
- Background: PubMed 31058623Khlef 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.
- Background: PubMed 27696311Alfawal 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. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
- Background: PubMed 29454369Alfawal 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.
- Background: PubMed 33158633Khlef 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.
- Derived from this study: PubMed 35295761Khlef HN, Hajeer MY. Is It Possible to Achieve Favorable Accelerated Dental Changes with No Periodontal Complications When Retracting Upper Anterior Teeth Assisted by Flapless Corticotomy Compared to Traditional Corticotomy? A Two-Arm Randomized Controlled Trial. ScientificWorldJournal. 2022 Mar 7;2022:4261248. doi: 10.1155/2022/4261248. eCollection 2022.
- Individual participant dataSharing planned: No
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Class II Malocclusion, Class II Malocclusion, Division 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanin Nizar Khlef, DDS,MSc principal investigator
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Mohammad Y Hajeer, DDS,MSc,PhD study chair
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Omar Heshmeh, DDS,MSc,PhD study director
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional corticotomy and Flapless corticotomy in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of en-masse retraction of upper anterior teeth. (time frame: The calculation of the rate of retraction will be done once the retraction procedures finish. It is expected to happen within 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847492, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.