Orthodontic Appliance ComplicationNCT07546058
Effect of Local Subperiosteal Zoledronic Acid Injection on the Survival of Orthodontic Miniscrews
A study testing Zoledronic Acid and Normal saline (0.9% sodium chloride) in people with Orthodontic Appliance Complication, run by Latakia University at 1 site in Syria.
Trial summary
Background: Orthodontic miniscrews are widely used as temporary anchorage devices; however, failure remains a clinical concern. Bisphosphonates may enhance bone stability, but evidence on their local application is limited. Read more about this study
- Who is it for?
- Ages 17 to 28 years
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Zoledronic Acid and Normal saline (0.9% sodium chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2024to 3 Feb 2026
- 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 17 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild to moderate skeletal Class II Division 1 malocclusion with full-cusp Class II molar relationship, ANB angle between 4° and 6°, normal maxilla-mandibular plane angle (25° ± 5°), and indication for first premolar extraction to reduce overjet.
Who cannot join
- Periodontal disease or alveolar bone loss.
- Craniofacial deformities.
- Cleft lip or palate.
- Impacted or missing teeth in the treatment area.
- Systemic diseases or current medication affecting bone metabolism.
- Poor gingival health.
- Smoking or inadequate oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Orthodontic miniscrews are widely used as temporary anchorage devices; however, failure remains a clinical concern. Bisphosphonates may enhance bone stability, but evidence on their local application is limited.
Objective: To evaluate the effect of local subperiosteal zoledronic acid (ZA) injection on miniscrew survival and peri-miniscrew inflammation.
Materials and Methods: This triple-blind, split-mouth randomized controlled trial included 68 patients requiring bilateral maxillary premolar extraction. Miniscrews were placed bilaterally, with one side randomly receiving a 0.5 mL solution of zoledronic acid at 1 mg/mL concentration and the contralateral side saline. Injections were administered weekly for three weeks. Orthodontic force (~250 g) was applied 24 hours after final injection. The primary outcome was miniscrew survival at 6 months. Paired comparisons were analyzed using McNemar test, with odds ratios (ORs) and 95% confidence intervals (CIs).
Read the detailed description
Anchorage in orthodontics refers to resistance against unwanted tooth movements during treatment. Numerous methods and devices have been utilized over time to reinforce anchorage. Although effective, these traditional techniques present certain limitations.
Recently, mini-implants, or temporary anchorage devices (TADs), have gained popularity as reliable tools for facilitating controlled tooth movement without relying on patient compliance. Nonetheless, miniscrews can encounter complications including mobility and failure during treatment. Clinically, miniscrew success is generally assessed by absence of inflammation, mobility, or significant pain, along with their capacity to withstand orthodontic forces. A systematic review and meta-analysis estimated that TAD failure occurs in approximately 13.5% of cases, with mandibular placements showing a higher failure rate (16.5%) compared to maxillary ones (11.0%).
Bisphosphonates (BPs) are synthetic compounds analogous to pyrophosphates.They are mainly prescribed to manage excessive bone resorption associated with skeletal disorders, primarily by modulating bone remodeling and repair.
The biological effects of bisphosphonates can be categorized into:
- Tissue level: BPs reduce bone turnover, thereby diminishing both bone resorption and formation.
- Cellular level: Osteoclasts are the primary targets, with bisphosphonates inhibiting their recruitment, suppressing activity, shortening lifespan, and modifying bone mineral properties to slow dissolution independently of cellular processes.
In oral surgery, bisphosphonates have been studied for their influence on implant osseointegration. Clinical trials in humans have reported similar improvements in implant stability and reductions in marginal bone loss. In orthodontics, bisphosphonates have shown promising results by significantly reducing root resorption, maintaining anchorage, and inhibiting osteoclast formation triggered by orthodontic forces, ultimately slowing tooth movement in experimental models. Recent evidence suggests that localized delivery of bisphosphonates is a beneficial adjunct to orthodontic therapy.35 Among bisphosphonates, zoledronic acid (ZA) is recognized as the most potent agent in clinical practice. A single intraoperative dose has shown positive outcomes in multiple bone healing and regeneration models.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Zoledronic Acid, Normal saline (0.9% sodium chloride)
- Keywords
- Orthodontic miniscrews, Temporary anchorage devices, Bisphosphonates, Zoledronic acid, Anchorage reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Also called Bisphosphonate
Zoledronic acid was prepared at a concentration of 1 mg/mL according to the manufacturer's instructions (ADMAC Pharmaceuticals). A volume of 0.5 mL was injected subperiosteally adjacent to miniscrews on the experimental side.
Dose calculation was based on conversion from animal studies using the human equivalent dose (HED) formula.39,40 The calculated HED was 0.0216 mg/kg, corresponding to approximately 1.296 mg for a 60-kg individual.
One week after placement, injections were administered weekly for three consecutive sessions.
Normal saline (0.9% sodium chloride)Drug
Three local subperiosteal injections of sterile 0.9% saline solution were administered at the orthodontic miniscrew insertion sites, beginning one week after placement and repeated at weekly intervals for three consecutive sessions, serving as an inert control without pharmacological effect.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Zoledronic Acid) | Experimental | zoledronic acid administered miniscrews Receives: Drug: Zoledronic Acid |
| Placebo / Saline Group | Placebo comparator | saline administered miniscrews Receives: Drug: Normal saline (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
Proportion of orthodontic miniscrews with no clinical mobility during follow-up, assessed by manual clinical examination
Measured: 6 months
Secondary outcomes (1)
Peri-miniscrew inflammation
assessed using a 3-point index: (0) healthy; (1) mucositis; (2) peri-implantitis with mobility and failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Dec 2024
- Primary completion2 Nov 2025
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadi Moawad, Latakia University
- Investigators
- Shadi G Moawad, Ph.D, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546058
- Sponsor's protocol ID
- LatakiaU
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldmann I, Bondemark L. Orthodontic anchorage: a systematic review. Angle Orthod. 2006 May;76(3):493-501. doi: 10.1043/0003-3219(2006)076[0493:OA]2.0.CO;2.
PubMed 16637733Ganzer N, Feldmann I, Bondemark L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):758-767. doi: 10.1016/j.ajodo.2018.07.011.
PubMed 30477773Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
PubMed 20152674Moghaddam SF, Mohammadi A, Behroozian A. The effect of sandblasting and acid etching on survival rate of orthodontic miniscrews: a split-mouth randomized controlled trial. Prog Orthod. 2021 Jan 7;22(1):2. doi: 10.1186/s40510-020-00347-z.
PubMed 33409700Kloehn SJ. Orthodontics-force or persuasion. Angle Orthod 1953; 23:55-65
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Subperiosteal Zoledronic Acid Injection on the Survival of Orthodontic Miniscrews
- ClinicalTrials.gov ID
- NCT07546058
- Acronym / sponsor ID
- LatakiaU
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontic miniscrews, Temporary anchorage devices, Bisphosphonates, Zoledronic acid, Anchorage reinforcement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 22 Apr 2026 (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.
Background: Orthodontic miniscrews are widely used as temporary anchorage devices; however, failure remains a clinical concern. Bisphosphonates may enhance bone stability, but evidence on their local application is limited.
Objective: To evaluate the effect of local subperiosteal zoledronic acid (ZA) injection on miniscrew survival and peri-miniscrew inflammation.
Materials and Methods: This triple-blind, split-mouth randomized controlled trial included 68 patients requiring bilateral maxillary premolar extraction. Miniscrews were placed bilaterally, with one side randomly receiving a 0.5 mL solution of zoledronic acid at 1 mg/mL concentration and the contralateral side saline. Injections were administered weekly for three weeks. Orthodontic force (~250 g) was applied 24 hours after final injection. The primary outcome was miniscrew survival at 6 months. Paired comparisons were analyzed using McNemar test, with odds ratios (ORs) and 95% confidence intervals (CIs).
Detailed description
Anchorage in orthodontics refers to resistance against unwanted tooth movements during treatment. Numerous methods and devices have been utilized over time to reinforce anchorage. Although effective, these traditional techniques present certain limitations.
Recently, mini-implants, or temporary anchorage devices (TADs), have gained popularity as reliable tools for facilitating controlled tooth movement without relying on patient compliance. Nonetheless, miniscrews can encounter complications including mobility and failure during treatment. Clinically, miniscrew success is generally assessed by absence of inflammation, mobility, or significant pain, along with their capacity to withstand orthodontic forces. A systematic review and meta-analysis estimated that TAD failure occurs in approximately 13.5% of cases, with mandibular placements showing a higher failure rate (16.5%) compared to maxillary ones (11.0%).
Bisphosphonates (BPs) are synthetic compounds analogous to pyrophosphates.They are mainly prescribed to manage excessive bone resorption associated with skeletal disorders, primarily by modulating bone remodeling and repair.
The biological effects of bisphosphonates can be categorized into:
- Tissue level: BPs reduce bone turnover, thereby diminishing both bone resorption and formation.
- Cellular level: Osteoclasts are the primary targets, with bisphosphonates inhibiting their recruitment, suppressing activity, shortening lifespan, and modifying bone mineral properties to slow dissolution independently of cellular processes.
In oral surgery, bisphosphonates have been studied for their influence on implant osseointegration. Clinical trials in humans have reported similar improvements in implant stability and reductions in marginal bone loss. In orthodontics, bisphosphonates have shown promising results by significantly reducing root resorption, maintaining anchorage, and inhibiting osteoclast formation triggered by orthodontic forces, ultimately slowing tooth movement in experimental models. Recent evidence suggests that localized delivery of bisphosphonates is a beneficial adjunct to orthodontic therapy.35 Among bisphosphonates, zoledronic acid (ZA) is recognized as the most potent agent in clinical practice. A single intraoperative dose has shown positive outcomes in multiple bone healing and regeneration models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Zoledronic Acid) | Experimental | Drug: Zoledronic Acidzoledronic acid administered miniscrews |
| Placebo / Saline Group | Placebo comparator | Drug: Normal saline (0.9% sodium chloride)saline administered miniscrews |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mild to moderate skeletal Class II Division 1 malocclusion with full-cusp Class II molar relationship, ANB angle between 4° and 6°, normal maxilla-mandibular plane angle (25° ± 5°), and indication for first premolar extraction to reduce overjet.
Key exclusion criteria (7 listed)
- Periodontal disease or alveolar bone loss.
- Craniofacial deformities.
- Cleft lip or palate.
- Impacted or missing teeth in the treatment area.
- Systemic diseases or current medication affecting bone metabolism.
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 |
|---|---|---|
| Zoledronic AcidAlso: BisphosphonateZoledronic acid was prepared at a concentration of 1 mg/mL according to the manufacturer's instructions (ADMAC Pharmaceuticals). A volume of 0.5 mL was injected subperiosteally adjacent to miniscrews on the experimental side. Dose calculation was based on conversion from animal studies using the human equivalent dose (HED) formula.39,40 The calculated HED was 0.0216 mg/kg, corresponding to approximately 1.296 mg for a 60-kg individual. One week after placement, injections were administered weekly for three consecutive sessions. | Drug | Intervention (Zoledronic Acid) |
| Normal saline (0.9% sodium chloride)Three local subperiosteal injections of sterile 0.9% saline solution were administered at the orthodontic miniscrew insertion sites, beginning one week after placement and repeated at weekly intervals for three consecutive sessions, serving as an inert control without pharmacological effect. | Drug | Placebo / Saline Group |
Primary outcome
Mobility
Time frame: 6 months
Proportion of orthodontic miniscrews with no clinical mobility during follow-up, assessed by manual clinical examination
1 secondary outcome
Peri-miniscrew inflammation
Time frame: 6 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 22 Apr 2026.
- Results publication: PubMed 16637733Feldmann I, Bondemark L. Orthodontic anchorage: a systematic review. Angle Orthod. 2006 May;76(3):493-501. doi: 10.1043/0003-3219(2006)076[0493:OA]2.0.CO;2.
- Results publication: PubMed 30477773Ganzer N, Feldmann I, Bondemark L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):758-767. doi: 10.1016/j.ajodo.2018.07.011.
- Results publication: PubMed 20152674Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
- Results publication: PubMed 33409700Moghaddam SF, Mohammadi A, Behroozian A. The effect of sandblasting and acid etching on survival rate of orthodontic miniscrews: a split-mouth randomized controlled trial. Prog Orthod. 2021 Jan 7;22(1):2. doi: 10.1186/s40510-020-00347-z.
- Results publicationKloehn SJ. Orthodontics-force or persuasion. Angle Orthod 1953; 23:55-65
- Individual participant dataSharing planned: No
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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.
Shadi G Moawad, Ph.D principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronic Acid and Normal saline (0.9% sodium chloride) in people with Orthodontic Appliance Complication, run by Latakia University at 1 site in Syria.
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 1 inclusion and 7 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 22 Apr 2026. 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 Syria. 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. Some participants in this study may receive a placebo. 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?
Mobility (time frame: 6 months). 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 NCT07546058, which also lists 5 linked publications.
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 22 Apr 2026.