OrthodonticsNCT02796911
Comparative Study of Different Bone Grafts in Accelerating Tooth Movement
A study testing Xenograft and Bioactive glass in people with Orthodontics, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment time. The current study will be carried to evaluate the effectiveness of different bone grafts with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- Xenograft and Bioactive glass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2015to 1 Jul 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A moderate 4-5mm crowding of the lower anterior teeth
- Good oral hygiene
- Healthy systemic condition
Who cannot join
- previous orthodontic treatment
- Probing depth values exceeding 3 mm
- Radiographic evidence of bone loss
- Regular administration medication that affects bone metabolism such as prolonged use of corticosteroids, or bisphosphonates and NSAIDs.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdelaziz University. Faculty of dentistry
Jeddah, 21589
About this study
Official title: Effectiveness of Bovine Derived Xenograft Versus Bioactive Glass With Periodontally Accelerated Osteogenic Orthodontics in Adults
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment time. The current study will be carried to evaluate the effectiveness of different bone grafts with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding.
Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated. Probing depth, bone density and root length will be also evaluated. The measurements will be recorded.
Read the detailed description
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) combines periodontal therapy with orthodontic therapy, which will minimize treatment time. The current study will be carried to evaluate the effectiveness of bovine derived xenograft versus bioactive glass with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding.
Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy on the labial side only, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding. Probing depth will be evaluated clinically whereas bone density and root length will be evaluated radiographically. The measurements will be recorded at day of surgery (baseline) (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
- Conditions
- Orthodontics
- Being tested
- Xenograft, Bioactive glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenograftDrug
Also called bovine derived xenograft
group II will be treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);
Bioactive glassDrug
group III will be treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).
| Study group | Role | What they receive |
|---|---|---|
| Corticotomy alone | No intervention | Group I will be treated with a modified technique of corticotomy assisted orthodontic treatment (CAOT) alone |
| Corticotomy + xenograft | Experimental | group II (included 6 females and 5 males) that treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy); Receives: Drug: Xenograft |
| Corticotomy + bioactive glass | Experimental | group III (included 7 females and 4 males) that treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt). Receives: Drug: Bioactive glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of tooth movement
The total duration of active orthodontic treatment will be estimated in weeks from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding.
Measured: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
Secondary outcomes (2)
Bone density
Bone density will be evaluated radiographically
Measured: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
Root length
Root length will be evaluated radiographically
Measured: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start1 Sep 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
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 OrthodonticsStudies 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
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha A. Bahammam, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796911
- Sponsor's protocol ID
- 029-16
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2016
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bahammam MA. Effectiveness of bovine-derived xenograft versus bioactive glass with periodontally accelerated osteogenic orthodontics in adults: a randomized, controlled clinical trial. BMC Oral Health. 2016 Nov 30;16(1):126. doi: 10.1186/s12903-016-0321-x.
PubMed 27903250
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bovine Derived Xenograft Versus Bioactive Glass With Periodontally Accelerated Osteogenic Orthodontics in Adults
- ClinicalTrials.gov ID
- NCT02796911
- Acronym / sponsor ID
- 029-16
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment time. The current study will be carried to evaluate the effectiveness of different bone grafts with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding.
Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated. Probing depth, bone density and root length will be also evaluated. The measurements will be recorded.
Detailed description
Objective: Periodontally accelerated osteogenic orthodontics(PAOO) combines periodontal therapy with orthodontic therapy, which will minimize treatment time. The current study will be carried to evaluate the effectiveness of bovine derived xenograft versus bioactive glass with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding.
Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy on the labial side only, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding. Probing depth will be evaluated clinically whereas bone density and root length will be evaluated radiographically. The measurements will be recorded at day of surgery (baseline) (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corticotomy alone | No intervention | –Group I will be treated with a modified technique of corticotomy assisted orthodontic treatment (CAOT) alone |
| Corticotomy + xenograft | Experimental | Drug: Xenograftgroup II (included 6 females and 5 males) that treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy); |
| Corticotomy + bioactive glass | Experimental | Drug: Bioactive glassgroup III (included 7 females and 4 males) that treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A moderate 4-5mm crowding of the lower anterior teeth
- Good oral hygiene
- Healthy systemic condition
Key exclusion criteria (4 listed)
- previous orthodontic treatment
- Probing depth values exceeding 3 mm
- Radiographic evidence of bone loss
- Regular administration medication that affects bone metabolism such as prolonged use of corticosteroids, or bisphosphonates and NSAIDs.
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 |
|---|---|---|
| XenograftAlso: bovine derived xenograftgroup II will be treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy); | Drug | Corticotomy + xenograft |
| Bioactive glassgroup III will be treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt). | Drug | Corticotomy + bioactive glass |
Primary outcome
Speed of tooth movement
Time frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
The total duration of active orthodontic treatment will be estimated in weeks from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding.
2 secondary outcomes
Bone density
Time frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
Root length
Time frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).
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 1 Apr 2024.
- Derived from this study: PubMed 27903250Bahammam MA. Effectiveness of bovine-derived xenograft versus bioactive glass with periodontally accelerated osteogenic orthodontics in adults: a randomized, controlled clinical trial. BMC Oral Health. 2016 Nov 30;16(1):126. doi: 10.1186/s12903-016-0321-x.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenograft and Bioactive glass in people with Orthodontics, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 3 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 1 Apr 2024. 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 Saudi Arabia. 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?
Speed of tooth movement (time frame: Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).). 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 NCT02796911, 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 1 Apr 2024.