Transverse Maxillary DeficiencyNCT07695584
Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinical Study
A study testing Expansion group in people with Transverse Maxillary Deficiency and Oxidative Stress, run by IRCCS Ospedale San Raffaele at 1 site in Turkey (Türkiye).
Trial summary
Rapid maxillary expansion is an orthopedic treatment used to correct transverse maxillary deficiency in growing patients. Mechanical forces generated during expansion may induce local biological responses, including changes in oxidative stress and antioxidant defense mechanisms. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Transverse Maxillary Deficiency, Oxidative Stress
- What is being tested?
- Expansion group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2011to 30 Jun 2012
- 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 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 10 and 13 years.
- Good general health.
- Fully erupted maxillary premolars.
- Healthy periodontal status, with probing depth of 3 mm or less.
- For the intervention group, a clinical indication for rapid maxillary expansion.
- For the control group, no orthodontic treatment planned during the observation period.
- Ability to comply with the clinical examination and gingival crevicular fluid sampling schedule.
- Written informed consent from the participant's parent or legal guardian and assent from the participant, where applicable.
Who cannot join
- Systemic disease.
- Current medication use that could influence periodontal, inflammatory, or oxidative status.
- Active periodontal disease.
- Probing depth greater than 3 mm.
- Inability to comply with the oral hygiene protocol or study visits.
Trial locations and contacts
1 site in 1 country.
About this study
Rapid maxillary expansion is an orthopedic treatment used to correct transverse maxillary deficiency in growing patients. Mechanical forces generated during expansion may induce local biological responses, including changes in oxidative stress and antioxidant defense mechanisms.
This prospective, non-randomized, controlled pilot study evaluated changes in oxidative and antioxidant biomarkers in gingival crevicular fluid during rapid maxillary expansion and the early retention period. Twenty-eight participants aged 10 to 13 years were included: 14 patients undergoing rapid maxillary expansion and 14 age- and sex-matched untreated controls.
Gingival crevicular fluid samples and periodontal measurements were collected at six corresponding time points. Malondialdehyde, reduced glutathione, glutathione peroxidase, and vitamin C were measured. The study aimed to characterize local biochemical changes associated with the treatment period and to compare their longitudinal patterns with those observed in untreated controls.
Read the detailed description
Rapid maxillary expansion is widely used to correct transverse maxillary deficiency in growing patients. Although its skeletal and dentoalveolar effects are well established, the local biochemical responses associated with active expansion and early retention remain incompletely characterized. Mechanical loading may increase the production of reactive oxygen species and alter antioxidant defense mechanisms within periodontal tissues.
The purpose of this study was to evaluate longitudinal changes in oxidative stress and antioxidant biomarkers measured in gingival crevicular fluid during rapid maxillary expansion and to compare these changes with those observed in an untreated control group.
Twenty-eight consecutively recruited orthodontic patients aged 10 to 13 years were included. Fourteen patients with a clinical indication for rapid maxillary expansion formed the intervention group. Fourteen untreated participants, matched by age and sex, formed the control group. Treatment allocation was not randomized because the decision to perform rapid maxillary expansion was based on clinical need.
Participants in the intervention group were treated with a modified Hyrax rapid maxillary expander. The appliance was initially maintained without activation and was subsequently activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the planned expansion was achieved. After active expansion, the screw was stabilized with composite resin and the appliance was maintained as a retention device.
Clinical periodontal assessments and gingival crevicular fluid sampling were performed at six time points: baseline; 24 hours after appliance placement; 7 days after appliance placement during the passive phase; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention. Control participants underwent the same assessment schedule without orthodontic intervention.
Gingival crevicular fluid was analyzed for malondialdehyde, reduced glutathione, glutathione peroxidase activity, and vitamin C. Biomarker values were normalized to total protein concentration. Periodontal measurements included gingival index, plaque index, probing depth, and keratinized tissue percentage.
The study was exploratory and no formal prospective sample size calculation was performed. The findings were intended to characterize local biochemical changes in gingival crevicular fluid and were not designed to provide direct evidence of skeletal or midpalatal suture remodeling.
- Conditions
- Transverse Maxillary Deficiency, Oxidative Stress
- Being tested
- Expansion group
- Keywords
- Rapid maxillary expansion, Gingival crevicular fluid, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expansion groupProcedure or surgery
A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Age- and sex-matched participants who did not receive orthodontic treatment during the observation period. Participants underwent the same periodontal examinations and gingival crevicular fluid sampling schedule as the intervention group. |
| Expansion | Experimental | A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period. Receives: Procedure: Expansion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival crevicular fluid malondialdehyde level
Malondialdehyde in gingival crevicular fluid was assessed using a thiobarbituric acid reactive substances method and normalized to total protein concentration. Higher values indicate greater local lipid peroxidation.
Measured: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Secondary outcomes (3)
Change in gingival crevicular fluid reduced glutathione level
Reduced glutathione was measured spectrophotometrically and normalized to total protein concentration
Measured: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Change in gingival crevicular fluid glutathione peroxidase activity
Glutathione peroxidase activity was measured spectrophotometrically and normalized to total protein concentration
Measured: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Change in gingival crevicular fluid vitamin C level
Vitamin C was measured using a colorimetric spectrophotometric method and normalized to total protein concentration.
Measured: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Mar 2011
- Primary completion31 May 2011
- Study completion30 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse Maxillary DeficiencyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Responsible party
- Principal investigator, Giorgio Gastaldi, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695584
- Sponsor's protocol ID
- Oxidative Stress Expansion
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data underlying the published results, together with the data dictionary, may be made available upon reasonable request to the corresponding author and subject to approval by the responsible institution and applicable ethical and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07695584
- Acronym / sponsor ID
- Oxidative Stress Expansion
- Conditions
- Transverse Maxillary Deficiency, Oxidative Stress
- Keywords
- Rapid maxillary expansion, Gingival crevicular fluid, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 31 May 2011 (actual)
- Study completion
- 30 Jun 2012 (actual)
- First posted
- 10 Jul 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.
Rapid maxillary expansion is an orthopedic treatment used to correct transverse maxillary deficiency in growing patients. Mechanical forces generated during expansion may induce local biological responses, including changes in oxidative stress and antioxidant defense mechanisms.
This prospective, non-randomized, controlled pilot study evaluated changes in oxidative and antioxidant biomarkers in gingival crevicular fluid during rapid maxillary expansion and the early retention period. Twenty-eight participants aged 10 to 13 years were included: 14 patients undergoing rapid maxillary expansion and 14 age- and sex-matched untreated controls.
Gingival crevicular fluid samples and periodontal measurements were collected at six corresponding time points. Malondialdehyde, reduced glutathione, glutathione peroxidase, and vitamin C were measured. The study aimed to characterize local biochemical changes associated with the treatment period and to compare their longitudinal patterns with those observed in untreated controls.
Detailed description
Rapid maxillary expansion is widely used to correct transverse maxillary deficiency in growing patients. Although its skeletal and dentoalveolar effects are well established, the local biochemical responses associated with active expansion and early retention remain incompletely characterized. Mechanical loading may increase the production of reactive oxygen species and alter antioxidant defense mechanisms within periodontal tissues.
The purpose of this study was to evaluate longitudinal changes in oxidative stress and antioxidant biomarkers measured in gingival crevicular fluid during rapid maxillary expansion and to compare these changes with those observed in an untreated control group.
Twenty-eight consecutively recruited orthodontic patients aged 10 to 13 years were included. Fourteen patients with a clinical indication for rapid maxillary expansion formed the intervention group. Fourteen untreated participants, matched by age and sex, formed the control group. Treatment allocation was not randomized because the decision to perform rapid maxillary expansion was based on clinical need.
Participants in the intervention group were treated with a modified Hyrax rapid maxillary expander. The appliance was initially maintained without activation and was subsequently activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the planned expansion was achieved. After active expansion, the screw was stabilized with composite resin and the appliance was maintained as a retention device.
Clinical periodontal assessments and gingival crevicular fluid sampling were performed at six time points: baseline; 24 hours after appliance placement; 7 days after appliance placement during the passive phase; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention. Control participants underwent the same assessment schedule without orthodontic intervention.
Gingival crevicular fluid was analyzed for malondialdehyde, reduced glutathione, glutathione peroxidase activity, and vitamin C. Biomarker values were normalized to total protein concentration. Periodontal measurements included gingival index, plaque index, probing depth, and keratinized tissue percentage.
The study was exploratory and no formal prospective sample size calculation was performed. The findings were intended to characterize local biochemical changes in gingival crevicular fluid and were not designed to provide direct evidence of skeletal or midpalatal suture remodeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Age- and sex-matched participants who did not receive orthodontic treatment during the observation period. Participants underwent the same periodontal examinations and gingival crevicular fluid sampling schedule as the intervention group. |
| Expansion | Experimental | Procedure: Expansion groupA tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 10 and 13 years.
- Good general health.
- Fully erupted maxillary premolars.
- Healthy periodontal status, with probing depth of 3 mm or less.
- For the intervention group, a clinical indication for rapid maxillary expansion.
Key exclusion criteria (5 listed)
- Systemic disease.
- Current medication use that could influence periodontal, inflammatory, or oxidative status.
- Active periodontal disease.
- Probing depth greater than 3 mm.
- Inability to comply with the oral hygiene protocol or study visits.
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 |
|---|---|---|
| Expansion groupA tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period. | Procedure or surgery | Expansion |
Primary outcome
Change in gingival crevicular fluid malondialdehyde level
Time frame: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Malondialdehyde in gingival crevicular fluid was assessed using a thiobarbituric acid reactive substances method and normalized to total protein concentration. Higher values indicate greater local lipid peroxidation.
3 secondary outcomes
Change in gingival crevicular fluid reduced glutathione level
Time frame: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Change in gingival crevicular fluid glutathione peroxidase activity
Time frame: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Change in gingival crevicular fluid vitamin C level
Time frame: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
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 10 Jul 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying the published results, together with the data dictionary, may be made available upon reasonable request to the corresponding author and subject to approval by the responsible institution and applicable ethical and data-protection requirements.
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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 Expansion group in people with Transverse Maxillary Deficiency and Oxidative Stress, run by IRCCS Ospedale San Raffaele at 1 site in Turkey (Türkiye).
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 5 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 10 Jul 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 Turkey (Türkiye). 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?
Change in gingival crevicular fluid malondialdehyde level (time frame: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.). 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 10 Jul 2026.