Bimaxillary ProtrusionNCT05183451
Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT
A study testing En- masse retraction and LLLT and En- masse retraction without LLLT in people with Bimaxillary Protrusion, run by Cairo University at 1 site in Egypt.
Trial summary
There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Protrusion
- What is being tested?
- En- masse retraction and LLLT and En- masse retraction without LLLT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2018to 25 Oct 2020
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult females
- Patients having bimaxillary dento- alveolar protrusion and Class I Molar relation
- Cases requiring maximum anchorage during retraction.
- Good general and oral health
Who cannot join
- Patients suffering from any systemic diseases interfering with tooth movement.
- Patients with extracted or missing permanent teeth. (except for third molars).
- Patients with badly decayed teeth (Other than 1st premolars).
- Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).
- Patients with previous orthodontic treatment
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-level Laser Therapy on the Rate of En-masse Retraction in Adult Females With Bimaxillary Dentoalveolar Protrusion: a Single-center Randomized Clinical Trial
There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.
Read the detailed description
Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper and lower incisors and increased procumbency of the lips thus suffering from poor facial esthetics. The conventional management of these patients is the extraction of the first premolars and retraction of the anterior teeth.
One of the treatment techniques is in the form of canine retraction followed by four incisors retraction. This conventional method takes tedious work and tremendous time, thus affecting the patients' satisfaction adversely. The other technique is retraction of the whole set of anterior teeth as one unit (Canine and incisors), which is referred to as "En-Masse retraction".
Enhancing the rate of orthodontic tooth movement has always been a supreme goal of orthodontic research hoping to raise the level of care delivered to patients, hence, increase patients' satisfaction.
One of the proposed modalities of increasing the rate of tooth movement is Low Level Laser Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar protrusion.
- Conditions
- Bimaxillary Protrusion
- Being tested
- En- masse retraction and LLLT, En- masse retraction without LLLT
- Keywords
- En-masse retraction, Rate of tooth movement, Low Level Laser Therapy (LLLT), 3D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En- masse retraction and LLLTProcedure or surgery
Also called Laser group, Group A
Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. LLLT will be applied on days 0,3,7,14 from extraction then repeated biweekly till the end of retraction.
En- masse retraction without LLLTProcedure or surgery
Also called No laser group, Group B
Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs.
| Study group | Role | What they receive |
|---|---|---|
| LG (Group A) | Experimental | En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. Retraction was done along with the application of LLLT till the end of retraction. Receives: Procedure: En- masse retraction and LLLT |
| NLG (Group B) | Active comparator | En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. No LLLT was applied to this group Receives: Procedure: En- masse retraction without LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of en-masse retraction
The antero-posterior movement of anterior teeth will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)
Measured: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Secondary outcomes (5)
Anterior teeth's root resorption
Assessed via comparing the pre \& post- retraction CBCTs using Lavender \& Malmgren Grading system
Measured: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Anterior teeth Tip and Torque
By comparing angular changes in the teeth's tip and torque in relation to reference planes
Measured: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Anchorage (Loss/ Gain)
By comparing linear and angular changes in the first molars in relation to reference planes
Measured: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
First molars' rotation
Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line
Measured: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Pain Associated
Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 0-10
Measured: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start2 Dec 2018
- Primary completion20 Aug 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bimaxillary ProtrusionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed El- Sayed Dehis, Cairo University
- Investigators
- Heba Mohamed E Dehis, Lecturer, Principal investigator, Cairo UniversityFoad A El-Sharaby, A. Professor, Study director, Cairo UniversityFaten H Eid, Professor, Study director, Cairo UniversityMushira Dahaba, Professor, Study director, Cairo UniversityYehya A Mostafa, Professor, Study director, Future University in Egypt (FUE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183451
- Sponsor's protocol ID
- FDCU-REC (2)/12-2018
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data will be available for researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
Publications
Dehis HM, El Sharaby FA, Eid FH, Mostafa YA. Effect of low-level laser therapy on en masse retraction in females with bimaxillary dentoalveolar protrusion : A single-center randomized clinical trial. J Orofac Orthop. 2025 Sep;86(5):284-297. doi: 10.1007/s00056-024-00525-2. Epub 2024 Jun 6.
PubMed 38842738
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy on the Rate of En-masse Retraction in Adult Females With Bimaxillary Dentoalveolar Protrusion: a Single-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05183451
- Acronym / sponsor ID
- FDCU-REC (2)/12-2018
- Conditions
- Bimaxillary Protrusion
- Keywords
- En-masse retraction, Rate of tooth movement, Low Level Laser Therapy (LLLT), 3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 10 Jan 2022 (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.
There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.
Detailed description
Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper and lower incisors and increased procumbency of the lips thus suffering from poor facial esthetics. The conventional management of these patients is the extraction of the first premolars and retraction of the anterior teeth.
One of the treatment techniques is in the form of canine retraction followed by four incisors retraction. This conventional method takes tedious work and tremendous time, thus affecting the patients' satisfaction adversely. The other technique is retraction of the whole set of anterior teeth as one unit (Canine and incisors), which is referred to as "En-Masse retraction".
Enhancing the rate of orthodontic tooth movement has always been a supreme goal of orthodontic research hoping to raise the level of care delivered to patients, hence, increase patients' satisfaction.
One of the proposed modalities of increasing the rate of tooth movement is Low Level Laser Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar protrusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LG (Group A) | Experimental | Procedure: En- masse retraction and LLLTEn- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. Retraction was done along with the application of LLLT till the end of retraction. |
| NLG (Group B) | Active comparator | Procedure: En- masse retraction without LLLTEn- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. No LLLT was applied to this group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult females
- Patients having bimaxillary dento- alveolar protrusion and Class I Molar relation
- Cases requiring maximum anchorage during retraction.
- Good general and oral health
Key exclusion criteria (6 listed)
- Patients suffering from any systemic diseases interfering with tooth movement.
- Patients with extracted or missing permanent teeth. (except for third molars).
- Patients with badly decayed teeth (Other than 1st premolars).
- Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).
- Patients with previous orthodontic treatment
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 |
|---|---|---|
| En- masse retraction and LLLTAlso: Laser group, Group ARetraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. LLLT will be applied on days 0,3,7,14 from extraction then repeated biweekly till the end of retraction. | Procedure or surgery | LG (Group A) |
| En- masse retraction without LLLTAlso: No laser group, Group BRetraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. | Procedure or surgery | NLG (Group B) |
Primary outcome
Rate of en-masse retraction
Time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
The antero-posterior movement of anterior teeth will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)
5 secondary outcomes
Anterior teeth's root resorption
Time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Anterior teeth Tip and Torque
Time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Anchorage (Loss/ Gain)
Time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
First molars' rotation
Time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Pain Associated
Time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
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 10 Jan 2022.
- Derived from this study: PubMed 38842738Dehis HM, El Sharaby FA, Eid FH, Mostafa YA. Effect of low-level laser therapy on en masse retraction in females with bimaxillary dentoalveolar protrusion : A single-center randomized clinical trial. J Orofac Orthop. 2025 Sep;86(5):284-297. doi: 10.1007/s00056-024-00525-2. Epub 2024 Jun 6.
- Individual participant dataSharing planned: Yes. Research data will be available for researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
Related trials for Bimaxillary Protrusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
Bimaxillary Proclination, Bimaxillary Protrusion
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Active, not recruiting
Effect of an AI Prediction Model of Facial Changes After Orthodontic Treatment of Patients With Bimaxillary Protrusion
Bimaxillary Protrusion
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.
Heba Mohamed E Dehis, Lecturer principal investigator
Cairo University
Foad A El-Sharaby, A. Professor study director
Cairo University
Faten H Eid, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing En- masse retraction and LLLT and En- masse retraction without LLLT in people with Bimaxillary Protrusion, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 6 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 10 Jan 2022. 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 Egypt. 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?
Rate of en-masse retraction (time frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year). 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 NCT05183451, which also lists 1 linked publication.
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 10 Jan 2022.