Orthodontic Appliance Complication[PLD]NCT03535285
Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines
A study testing Periodontal ligament distraction in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
Surgical modification technique try to get bodily movement during upper canine retraction. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Periodontal ligament distraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 15 Dec 2017
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Orthodontic patients needed extraction of upper first premolars, with age range from 18 - 25 years old.
- All patients were medically free. (See Appendix II)
- No previous orthodontic treatment.
- Adequate oral hygiene and periodontally healthy teeth.
- The canines were almost leveled and aligned.
- Maximum anchorage requirements.
- Healthy canines; no deep carious lesions, no endodontic lesions, no root canal treatment, nor internal or external root resorption.
- All patients were informed of the procedure and signed the consents.
Who cannot join
- Subjects were excluded from the study when:
- They failed to keep several consecutive appointments.
- Oral hygiene was subjectively judged as deteriorating during the preliminary stages of patient preparation.
- Compliance with the instructions provided was inadequate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines in Adult Patients (Split-mouth Randomized Clinical Trial)
Surgical modification technique try to get bodily movement during upper canine retraction.
Read the detailed description
I- Original surgical technique (Liou and Huang technique, 1998) :
On the conventional surgical side, (the control side), the intersepital bone was undermined by two vertical cuts on the mesio-buccal and mesio-palatal line angles of the first premolar socket. They were connected at the base of the socket by an oblique cut. The surgical round bur was held parallel to the long axis of the canine and moved buccolingually, while shaving the interseptal bone buccolingual (back-and-forth) shaving movements were reduced the thickness of the interseptal bone by approximately 1 mm
II- Modified surgical technique:
In the surgical modification side, (the experimental side), intra-alveolar mesio-buccal and mesio-palatal cuts and interseptal bone shaving were done by surgical round bur and copious irrigation, without the oblique cut since it was done blindly in the original surgical technique. A buccal semilunar flap was opened on the apical area of canine-premolar region. The surgical pin helped also in location of the point of initial drilling of the apical horizontal cut from buccal approach, when the surgical pin's socket arm rested on the depth of the socket, the vestibular arm marked the point of access. It also estimated mesiodeistal extension of the apical horizontal cut. The apical horizontal cut was started from the socket apex to half way of the interseptal bone mesiodistally as an extension and for the depth, Mallet and Chisel were used from the cortical bone to reach the mesio-palatal cut. The flap was sutured. This surgical modification step provided more predictability and safer surgery than the blind oblique cut in the original surgical technique.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Periodontal ligament distraction
- Keywords
- periodontal ligament, dentoalveolar, distraction, orthodontic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal ligament distractionProcedure or surgery
Also called Acceleration of canine retraction
decrease the bony resistant during canine retration
| Study group | Role | What they receive |
|---|---|---|
| Surgical modification side | Experimental | Periodontal ligament distraction without the oblique cuts but with apical horizontal cut Receives: Procedure: Periodontal ligament distraction |
| Conventional surgery | Active comparator | Periodontal ligament distraction Receives: Procedure: Periodontal ligament distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tipping of the canines
- Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder \& Potable dental x-ray unit
- Panoramic radiograph .
Measured: 3-4 weeks
Rate of canines retraction
Digital models using 3shape scanner and Ortho-Analyzer software
Measured: 3-4 weeks
Rotation of the canines
Digital models using 3shape scanner and Ortho-Analyzer software
Measured: 3-4 weeks
Secondary outcomes (7)
Amount of anchorage loss
Digital models using 3shape scanner and Ortho-Analyzer software
Measured: 3-4 weeks
Tipping of the molars
- Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder \& Potable dental x-ray unit
- Panoramic radiograph.
Measured: 3-4 weeks
The apical root resorption scores
Periapical radiograph using Parallel technique (x-ray sensor, X-ray sensor holder \& Potable dental x-ray unit
Measured: 3-4 weeks
Pulp Vitality
Cold application (Ethyl Chloride)
Measured: 3-4 weeks
Gingival index
Periodontal probe
Measured: 3-4 weeks
Periodontal index
Periodontal probe
Measured: 3-4 weeks
Pain
Numeric rating scale (NRS) for pain
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start15 Jun 2017
- Primary completion15 Aug 2017
- Study completion15 Dec 2017
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 Orthodontic Appliance ComplicationStudies 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
- Model description
- Split-mouth
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monaser Mobarak, Cairo University
- Investigators
- Monaser M Elashik, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535285
- Sponsor's protocol ID
- 11111
- Acronym
- [PLD]
- Status last verified
- May 2018
- First submitted
- 10 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. doi: 10.1016/s0889-5406(98)70181-7.
PubMed 9790320
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines in Adult Patients (Split-mouth Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03535285
- Acronym / sponsor ID
- [PLD] / 11111
- Conditions
- Orthodontic Appliance Complication
- Keywords
- periodontal ligament, dentoalveolar, distraction, orthodontic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 24 May 2018 (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.
Surgical modification technique try to get bodily movement during upper canine retraction.
Detailed description
I- Original surgical technique (Liou and Huang technique, 1998) :
On the conventional surgical side, (the control side), the intersepital bone was undermined by two vertical cuts on the mesio-buccal and mesio-palatal line angles of the first premolar socket. They were connected at the base of the socket by an oblique cut. The surgical round bur was held parallel to the long axis of the canine and moved buccolingually, while shaving the interseptal bone buccolingual (back-and-forth) shaving movements were reduced the thickness of the interseptal bone by approximately 1 mm
II- Modified surgical technique:
In the surgical modification side, (the experimental side), intra-alveolar mesio-buccal and mesio-palatal cuts and interseptal bone shaving were done by surgical round bur and copious irrigation, without the oblique cut since it was done blindly in the original surgical technique. A buccal semilunar flap was opened on the apical area of canine-premolar region. The surgical pin helped also in location of the point of initial drilling of the apical horizontal cut from buccal approach, when the surgical pin's socket arm rested on the depth of the socket, the vestibular arm marked the point of access. It also estimated mesiodeistal extension of the apical horizontal cut. The apical horizontal cut was started from the socket apex to half way of the interseptal bone mesiodistally as an extension and for the depth, Mallet and Chisel were used from the cortical bone to reach the mesio-palatal cut. The flap was sutured. This surgical modification step provided more predictability and safer surgery than the blind oblique cut in the original surgical technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Surgical modification side | Experimental | Procedure: Periodontal ligament distractionPeriodontal ligament distraction without the oblique cuts but with apical horizontal cut |
| Conventional surgery | Active comparator | Procedure: Periodontal ligament distractionPeriodontal ligament distraction |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Orthodontic patients needed extraction of upper first premolars, with age range from 18 - 25 years old.
- All patients were medically free. (See Appendix II)
- No previous orthodontic treatment.
- Adequate oral hygiene and periodontally healthy teeth.
- The canines were almost leveled and aligned.
Key exclusion criteria (4 listed)
- They failed to keep several consecutive appointments.
- Oral hygiene was subjectively judged as deteriorating during the preliminary stages of patient preparation.
- Compliance with the instructions provided was inadequate.
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 ligament distractionAlso: Acceleration of canine retractiondecrease the bony resistant during canine retration | Procedure or surgery | Conventional surgery, Surgical modification side |
Primary outcome
Tipping of the canines
Time frame: 3-4 weeks
1. Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder \& Potable dental x-ray unit 2. Panoramic radiograph .
Rate of canines retraction
Time frame: 3-4 weeks
Digital models using 3shape scanner and Ortho-Analyzer software
Rotation of the canines
Time frame: 3-4 weeks
Digital models using 3shape scanner and Ortho-Analyzer software
7 secondary outcomes
Amount of anchorage loss
Time frame: 3-4 weeks
Tipping of the molars
Time frame: 3-4 weeks
The apical root resorption scores
Time frame: 3-4 weeks
Pulp Vitality
Time frame: 3-4 weeks
Gingival index
Time frame: 3-4 weeks
Periodontal index
Time frame: 3-4 weeks
Pain
Time frame: 3-4 weeks
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 25 May 2018.
- Results publication: PubMed 9790320Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. doi: 10.1016/s0889-5406(98)70181-7.
- periodontal ligament distractionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Monaser M Elashik, Master principal investigator
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 Periodontal ligament distraction in people with Orthodontic Appliance Complication, 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 8 inclusion and 4 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 25 May 2018. 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?
Tipping of the canines (time frame: 3-4 weeks). The study lists 3 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 NCT03535285, 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 25 May 2018.