Class II MalocclusionPhase 2/3NCT05466344
the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One
A Phase 2/3 study testing Herbst Group and TFBC Group in people with Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint. Study design: Prospective randomized clinical study. Study setting and population: This study will be conducted on twenty orthodontic patients. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Herbst Group and TFBC Group
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to 15 Apr 2022
- Phase
- Phase 2/3
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be selected based on the following inclusion criteria:
- Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°). With agefrom 18 to 25 years.
- Mandibular arch with minimum (up to 4mm) or no crowding.
- All permanent teeth are erupted (3rd molar not included).
- Good oral and general health.
- No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
- No previous orthodontic treatment.
Who cannot join
- 1. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
- 2. Patients with untreated decay or any endodontic lesions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mahmoud Mohammad Fathy Abo - Elmahasen
Maadi, Cairo Governorate, 11311
About this study
Official title: Assessment of the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One; A Randomized Clinical Trial
This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint.
Study design:
Prospective randomized clinical study.
Study setting and population:
This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study.
Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion
Read the detailed description
Participants will be selected based on the following inclusion criteria:
- Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°).
- Mandibular arch with minimum (up to 4mm) or no crowding.
- All permanent teeth are erupted (3rd molar not included).
- Good oral and general health.
- No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
- No previous orthodontic treatment. outcomes measures:
- primary outcome: comparison of condylar volume of Herbst group versus TFBC group.
- secondary outcome: Measurement of of condylar volume within each group (Herbst group and TFBC group)
Treatment steps:
As for Group Ι:
- Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance.
- The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured leaving an extended part of the plate in the oral cavity which contain the soldered ball housing.
- The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint.
- Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally.
- When reactivation of the telescopic piston is needed, extension rings are used.
As for Group ΙΙ:
- The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment.
- Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches.
- Installation of the Twin Force Bite Corrector appliance for 4 to 6 months.
- Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months.
- Finally follow finishing steps for each patient.
Observations:
Changes in the condylar volume and changes in position of the condyle in relation to glenoid fossa as a result of remodeling process before and after the fixed functional orthopedic treatment at each group.
- Conditions
- Class II Malocclusion
- Being tested
- Herbst Group, TFBC Group
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbst GroupDevice
Also called Group I
- Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance.
- The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured leaving an extended part of the plate in the oral cavity which contain the soldered ball housing.
- The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint.
- Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally.
- When reactivation of the telescopic piston is needed, extension rings are used.
TFBC GroupDevice
Also called Group II
- The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment.
- Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches.
- Installation of the Twin Force Bite Corrector appliance for 4 to 6 months.
- Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months.
- Finally follow finishing steps for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Herbst Group | Active comparator | Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the type IV Herbst appliance (mini plate anchored appliance). The age of patients will be (18-20y). Receives: Device: Herbst Group |
| TFBC Group | Active comparator | Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the Twin Force Bite Corrector appliance (dentally anchored appliance). The age of patients will be (18-20y). Receives: Device: TFBC Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of condylar volume of Herbst group versus TFBC group
three dimensional automatic measurement of condylar volume as one unit by Romexis software
Measured: nine months
Secondary outcomes (1)
Measurement of of condylar volume within each group (Herbst group and TFBC group)
three dimensional automatic measurement of condylar volume as one unit by Romexis software
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Jun 2020
- Primary completion10 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be selected based on the following inclusion criteria: 1. Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°). With agefrom 18 to 25 years. 2. Mandibular arch with minimum (up to 4mm) or no crowding. 3. All permanent teeth are erupted (3rd molar not included). 4. Good oral and general health. 5. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement. 6. No previous orthodontic treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud M. Fathy Aboelmahasen, Al-Azhar University
- Investigators
- Mahmoud Fathy, PHD, Principal investigator, Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466344
- Sponsor's protocol ID
- 603/307
- Status last verified
- Jul 2022
- First submitted
- 16 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05466344
- Acronym / sponsor ID
- 603/307
- Conditions
- Class II Malocclusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 20 Jul 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.
This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint.
Study design:
Prospective randomized clinical study.
Study setting and population:
This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study.
Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion
Detailed description
Participants will be selected based on the following inclusion criteria:
- Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°).
- Mandibular arch with minimum (up to 4mm) or no crowding.
- All permanent teeth are erupted (3rd molar not included).
- Good oral and general health.
- No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
- No previous orthodontic treatment. outcomes measures:
- primary outcome: comparison of condylar volume of Herbst group versus TFBC group.
- secondary outcome: Measurement of of condylar volume within each group (Herbst group and TFBC group)
Treatment steps:
As for Group Ι:
- Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance.
- The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured leaving an extended part of the plate in the oral cavity which contain the soldered ball housing.
- The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint.
- Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally.
- When reactivation of the telescopic piston is needed, extension rings are used.
As for Group ΙΙ:
- The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment.
- Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches.
- Installation of the Twin Force Bite Corrector appliance for 4 to 6 months.
- Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months.
- Finally follow finishing steps for each patient.
Observations:
Changes in the condylar volume and changes in position of the condyle in relation to glenoid fossa as a result of remodeling process before and after the fixed functional orthopedic treatment at each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be selected based on the following inclusion criteria: 1. Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°). With agefrom 18 to 25 years. 2. Mandibular arch with minimum (up to 4mm) or no crowding. 3. All permanent teeth are erupted (3rd molar not included). 4. Good oral and general health. 5. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement. 6. No previous orthodontic treatment.
| Arm | Type | Receives |
|---|---|---|
| Herbst Group | Active comparator | Device: Herbst GroupInclude ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the type IV Herbst appliance (mini plate anchored appliance). The age of patients will be (18-20y). |
| TFBC Group | Active comparator | Device: TFBC GroupInclude ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the Twin Force Bite Corrector appliance (dentally anchored appliance). The age of patients will be (18-20y). |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants will be selected based on the following inclusion criteria:
Key exclusion criteria (2 listed)
- 1. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
- 2. Patients with untreated decay or any endodontic lesions.
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 |
|---|---|---|
| Herbst GroupAlso: Group I1. Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance. 2. The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured leaving an extended part of the plate in the oral cavity which contain the soldered ball housing. 3. The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint. 4. Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally. 5. When reactivation of the telescopic piston is needed, extension rings are used. | Device | Herbst Group |
| TFBC GroupAlso: Group II1. The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment. 2. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches. 3. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months. 4. Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months. 5. Finally follow finishing steps for each patient. | Device | TFBC Group |
Primary outcome
comparison of condylar volume of Herbst group versus TFBC group
Time frame: nine months
three dimensional automatic measurement of condylar volume as one unit by Romexis software
1 secondary outcome
Measurement of of condylar volume within each group (Herbst group and TFBC group)
Time frame: nine 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 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Class II Malocclusion
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
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
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.
Mahmoud Fathy, PHD principal investigator
Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Herbst Group and TFBC Group in people with Class II Malocclusion, run by Al-Azhar 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 7 inclusion and 2 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 Jul 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
comparison of condylar volume of Herbst group versus TFBC group (time frame: nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2022.