Distraction of BoneNCT05814185
Distractor Effect on Pain and Vitality
A study testing Periodontal distractor in people with Distraction of Bone, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the present study was to evaluate the effect of two and four activations /day of periodontal distractor on pain intensity and pulp vitality of maxillary canine. Read more about this study
- Who is it for?
- Ages 16 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Distraction of Bone
- What is being tested?
- Periodontal distractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 15 Oct 2022
- 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 16 to 22 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Orthodontic Patients need extraction of first permanent premolar for orthodontic reasons (dentoalveolar maxillary protrusion, Class II div 1 malocclusion)
- No history of previous orthodontic treatment
- Absence of any systemic disease
- Good oral hygiene and healthy gums look, with no signs of redness, edema, or bleeding during brushing (periodontal inflammation)
- Highly motivation and cooperation
Who cannot join
- Medically compromised patients
- Use of medication that may affect tooth movement during the period of the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine, for Girls, Al Azhar University
Cairo, Nasr City, 02
About this study
Official title: The Effect of Two and Four Activations Per Day of the Periodontal Distractor on Pain Intensity and Pulp Vitality of Maxillary Canine: Randomized Clinical Trial
The aim of the present study was to evaluate the effect of two and four activations /day of periodontal distractor on pain intensity and pulp vitality of maxillary canine.
Read the detailed description
Orthodontic therapy is generally referred to as a lengthy process because a good orthodontic treatment normally takes 18 to 24 months to finish.
Long-term orthodontic treatment has a number of disadvantages, including as poor psychosocial effects on patients, white spots, long-term enamel damage, gingival recession, and root resorption.
The rate of tooth movement that can be achieved is a major determinant of orthodontic treatment time. Many studies have been conducted to determine the pace of orthodontic tooth movement. The majority of these studies demonstrate about 1mm of tooth movement per month.
As a result, finding treatment options that reduce treatment time without compromising results is a main focus of orthodontic research.
The approaches for hastening tooth movement rely on inducing a biological tissue reaction. These procedures are classified into two types based on their level of intrusion: conservative (biological, physical, and biomechanical measures) and surgical techniques Prostaglandins are the most often used biological agents , interleukins , leukotriene , vitamin D platelet rich plasma .Mechanical or physical approach include direct electrical current , pulsed electromagnetic field , low-energy laser , and Vibration Oral surgical procedures quicken orthodontic treatment by affecting the continuity of the alveolar bone resulting in a decrease in bone density and a corresponding reduction in the bone's resistance to orthodontic tooth movement . Surgical approach depends on Regional Acceleratory Phenomenon (RAP) which is a method to speed up orthodontic treatment by accelerating bone remodeling rates and bone density. The RAP is a series of tissue reactions that occur as a damaged bone heals . These surgical methods including corticotomy , bone perforation , Distraction osteogenesis is also one of surgical methods that allow rapid canine retraction .
The technique of distraction of the periodontal ligament (PDD) was introduced for rapid tooth movement then, dento alveolar distraction (DAD) was performed to achieve rapid tooth movement using the principles of distraction osteogenesis The canine was distracted by distractor twice daily for a total about 0.4 mm per day . It has been reported in literature that up to 2 mm is distracted per day (four activations of 0.5 mm each) . The distractor was activated till the distal surface of canine became in contact with the mesial surface of second premolar.
Previous Studies of periodontal distractor have been mainly focused on the assessment of the rate and angular changes on retracted canine. No clinical study has attempted to investigate pain intensity or pulp vitality for both activation protocols of periodontal distractor during rapid canine retraction. Therefore, the aim of the present study was to evaluate the effect of two and four activations/day of periodontal distractor on pain intensity and pulp vitality of maxillary canine.
- Conditions
- Distraction of Bone
- Being tested
- Periodontal distractor
- Medical subject headings
- Diastasis, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal distractorDevice
different activation protocols of periodontal distractor
| Study group | Role | What they receive |
|---|---|---|
| Canine retraction was done by periodontal distractor with two activations per day. | Experimental | group 1 Receives: Device: Periodontal distractor |
| Canine retraction was done by periodontal distractor with four activations per day. | Experimental | group 2 Receives: Device: Periodontal distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
evaluation of pain intensity by Visual Analogue scale.minimum 0 and maximum value 10.
Measured: 1st 48 hour after intervention (from the time of distractor placement until the end of the 2nd day)
pain intensity
evaluation of pain intensity by Visual Analogue scale.minimum 0 and maximum value 10
Measured: during each activation of the distractor,(up to 1 minute during moving the key of distractor)
pain intensity
evaluation of pain intensity by Visual Analogue scale. minimum 0 and maximum value 10
Measured: up to 6 hours on the four activations group and up to 12 hours on two activations group.
pulp vitality
vitality by Electric pulp tester.positive reading is better
Measured: before and after canine retraction (up to one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Feb 2021
- Primary completion1 Aug 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distraction of BoneStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mossad, Al-Azhar University
- Investigators
- Alaa M. Eldriny, Lecturer, Principal investigator, Assistant Lecturer of Orthodontics,Al Azhar University, Cairo, Egypt.Ahmed A. Salama, professor, Study director, Professor of Orthodontics, Al Azhar University, Cairo, Egypt.Osama S. El-Shal, professor, Study director, Professor of periodontology Al Azhar University, Cairo, Egypt.Maha M. Mohamed, professor, Study director, Assistant professor of Orthodontics, Al Azhar University, Cairo, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814185
- Sponsor's protocol ID
- PDL distractor
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two and Four Activations Per Day of the Periodontal Distractor on Pain Intensity and Pulp Vitality of Maxillary Canine: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05814185
- Acronym / sponsor ID
- PDL distractor
- Conditions
- Distraction of Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 14 Apr 2023 (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.
The aim of the present study was to evaluate the effect of two and four activations /day of periodontal distractor on pain intensity and pulp vitality of maxillary canine.
Detailed description
Orthodontic therapy is generally referred to as a lengthy process because a good orthodontic treatment normally takes 18 to 24 months to finish.
Long-term orthodontic treatment has a number of disadvantages, including as poor psychosocial effects on patients, white spots, long-term enamel damage, gingival recession, and root resorption.
The rate of tooth movement that can be achieved is a major determinant of orthodontic treatment time. Many studies have been conducted to determine the pace of orthodontic tooth movement. The majority of these studies demonstrate about 1mm of tooth movement per month.
As a result, finding treatment options that reduce treatment time without compromising results is a main focus of orthodontic research.
The approaches for hastening tooth movement rely on inducing a biological tissue reaction. These procedures are classified into two types based on their level of intrusion: conservative (biological, physical, and biomechanical measures) and surgical techniques Prostaglandins are the most often used biological agents , interleukins , leukotriene , vitamin D platelet rich plasma .Mechanical or physical approach include direct electrical current , pulsed electromagnetic field , low-energy laser , and Vibration Oral surgical procedures quicken orthodontic treatment by affecting the continuity of the alveolar bone resulting in a decrease in bone density and a corresponding reduction in the bone's resistance to orthodontic tooth movement . Surgical approach depends on Regional Acceleratory Phenomenon (RAP) which is a method to speed up orthodontic treatment by accelerating bone remodeling rates and bone density. The RAP is a series of tissue reactions that occur as a damaged bone heals . These surgical methods including corticotomy , bone perforation , Distraction osteogenesis is also one of surgical methods that allow rapid canine retraction .
The technique of distraction of the periodontal ligament (PDD) was introduced for rapid tooth movement then, dento alveolar distraction (DAD) was performed to achieve rapid tooth movement using the principles of distraction osteogenesis The canine was distracted by distractor twice daily for a total about 0.4 mm per day . It has been reported in literature that up to 2 mm is distracted per day (four activations of 0.5 mm each) . The distractor was activated till the distal surface of canine became in contact with the mesial surface of second premolar.
Previous Studies of periodontal distractor have been mainly focused on the assessment of the rate and angular changes on retracted canine. No clinical study has attempted to investigate pain intensity or pulp vitality for both activation protocols of periodontal distractor during rapid canine retraction. Therefore, the aim of the present study was to evaluate the effect of two and four activations/day of periodontal distractor on pain intensity and pulp vitality of maxillary canine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canine retraction was done by periodontal distractor with two activations per day. | Experimental | Device: Periodontal distractorgroup 1 |
| Canine retraction was done by periodontal distractor with four activations per day. | Experimental | Device: Periodontal distractorgroup 2 |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Orthodontic Patients need extraction of first permanent premolar for orthodontic reasons (dentoalveolar maxillary protrusion, Class II div 1 malocclusion)
- No history of previous orthodontic treatment
- Absence of any systemic disease
- Good oral hygiene and healthy gums look, with no signs of redness, edema, or bleeding during brushing (periodontal inflammation)
- Highly motivation and cooperation
Key exclusion criteria (2 listed)
- Medically compromised patients
- Use of medication that may affect tooth movement during the period of the study
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 |
|---|---|---|
| Periodontal distractordifferent activation protocols of periodontal distractor | Device | Canine retraction was done by periodontal distractor with four activations per day., Canine retraction was done by periodontal distractor with two activations per day. |
Primary outcome
pain intensity
Time frame: 1st 48 hour after intervention (from the time of distractor placement until the end of the 2nd day)
evaluation of pain intensity by Visual Analogue scale.minimum 0 and maximum value 10.
pain intensity
Time frame: during each activation of the distractor,(up to 1 minute during moving the key of distractor)
evaluation of pain intensity by Visual Analogue scale.minimum 0 and maximum value 10
pain intensity
Time frame: up to 6 hours on the four activations group and up to 12 hours on two activations group.
evaluation of pain intensity by Visual Analogue scale. minimum 0 and maximum value 10
pulp vitality
Time frame: before and after canine retraction (up to one month)
vitality by Electric pulp tester.positive reading is better
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 14 Apr 2023.
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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.
Alaa M. Eldriny, Lecturer principal investigator
Assistant Lecturer of Orthodontics,Al Azhar University, Cairo, Egypt.
Ahmed A. Salama, professor study director
Professor of Orthodontics, Al Azhar University, Cairo, Egypt.
Osama S. El-Shal, professor study director
Professor of periodontology Al Azhar University, Cairo, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal distractor in people with Distraction of Bone, 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 5 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 14 Apr 2023. 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?
pain intensity (time frame: 1st 48 hour after intervention (from the time of distractor placement until the end of the 2nd day)). 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?
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 14 Apr 2023.