Anterior CrossbiteNCT06858033
Evaluation of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Periodontal Health and Salivary Parameters
A study testing Clear aligner and Labiolingual spring hawley in people with Anterior Crossbite, run by Ozge Gungor at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Anterior Crossbite
- What is being tested?
- Clear aligner and Labiolingual spring hawley
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 10 Nov 2024
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dental anterior crossbite
Who cannot join
- Skeletal anterior crossbite
- Systemic disease
- Regular medication use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
Antalya, Konyaaltı, 07058
About this study
Official title: Assessment of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Children's Oral Microflora and Salivary Parameters
Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients.
Method: A total of 30 pediatric patients aged 7-12 years were treated with a total of 30 appliances including 15 clear aligners (Group A) and 15 labiolingual spring hawleys (Group B). In the clinical examination of the patients, dental caries status was evaluated by DMFT and dft index, periodontal health status was evaluated by probing pocket depth measurements and plaque, gingival and probing bleeding indices. In addition, saliva and dental plaque samples were taken and salivary parameters and microbiologic structure of plaque were analyzed. All these procedures were performed in 2 different time periods for each patient; before and after the treatment. The results were statistically evaluated using SPSS (SPSS Statistics v23.0 for Windows, Chicago, IL, USA).
Read the detailed description
In the clinical examination of the participants, dental caries status was evaluated by DMFT and dft index, and periodontal health status was evaluated by probing pocket depth measurements; PI, GI, SDI. In addition, saliva and dental plaque samples were taken and salivary parameters (flow rate, pH and buffering capacity) and microbiological structure of plaque were analyzed.
- Conditions
- Anterior Crossbite
- Being tested
- Clear aligner, Labiolingual spring hawley
- Keywords
- Clear aligner, Labiolingual spring hawley, Oral health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear alignerDevice
The effects of treatment on periodontal parameters (plaque index, gingival index, bleeding index on probing), salivary parameters (stimulated/unstimulated flow rate, stimulated/unstimulated pH, buffering capacity) and oral microorganism counts (S. mitis, S. salivarius, S. mutans, C. albicans) of children treated with labiolingual spring hawley and clear aligners were investigated.
Labiolingual spring hawleyDevice
The effects of treatment on periodontal parameters (plaque index, gingival index, bleeding index on probing), salivary parameters (stimulated/unstimulated flow rate, stimulated/unstimulated pH, buffering capacity) and oral microorganism counts (S. mitis, S. salivarius, S. mutans, C. albicans) of children treated with labiolingual spring hawley and clear aligners were investigated.
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner users | Experimental | Patients who were treated with clear aligners were referred to as 'clear aligner users'. Receives: Device: Clear aligner |
| Labiolingual spring hawley users | Experimental | Patients who were treated with clear aligners were referred to as 'Labiolingual spring hawle users'. Receives: Device: Labiolingual spring hawley |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIaque index (PI)
Based on Silness-Löe (1963, 1967) PI values, bacterial plaque and plaque thickness in direct contact with the marginal gingiva are evaluated. The evaluation is made with the Williams-marked University of Michigan 'O' periodontal probe, and PI values are recorded from a total of 4 surfaces of each tooth included in the study, namely mesial, distal, buccal and lingual. The averages of these values are calculated for each patient. The average scores obtained are evaluated in the 0-3 score range. An increase in the calculated scores indicates that periodontal health is negatively affected.
Measured: 3 months
DMFT index
To determine the DMFT index score, decayed teeth in permanent teeth are indicated as "D", lost teeth extracted due to decay are indicated as "M", and filled teeth are indicated as "F". The DMFT index is calculated by adding the D, M, F values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.
Measured: 3 months
Oral microorganisms count
- mitis, S. salivarius, S.mutans, C. albicans (cfu/ml)
Measured: 3 months
Gingival index (GI)
The degree of gingivitis is assessed using the Silness-Löe (1963, 1967) GI. The average of the measurements taken from four sides of the tooth determines the GI score of the tooth, and the average of the measurements of all teeth determines the individual's gingival index score. The scores obtained are evaluated in the range of 0-3. An increase in the calculated scores indicates that periodontal health is negatively affected.
Measured: 3 months
Bleeding on probing index (BOP)
In order to determine the inflammatory status of the pocket base and pocket epithelium, a score is given as positive (+) or negative (-) according to whether there is bleeding in the sulcus 20 seconds after the pocket depth measurement from a total of 4 surfaces of the teeth, mesial, distal, buccal and lingual. BOP is calculated as a score by dividing the number of bleeding teeth by the total number of tooth surfaces in each patient. An increase in the calculated scores indicates that periodontal health is negatively affected.
Measured: 3 months
dft index
The dft Index is the calculated form of the DMFT index for primary teeth. When calculating the dft group index, missing teeth are not included in the calculation. Because it is difficult to diagnose the reason for the loss of primary teeth and there is a high probability of error. For this reason, the number of decayed and filled teeth is calculated during the examination. Decayed teeth are indicated with "d" and filled teeth with "f". The dft index is calculated by adding the d and f values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Jun 2024
- Primary completion10 Jun 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior CrossbiteStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozge Gungor
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor-investigator, Ozge Gungor, Akdeniz University
- Investigators
- Özge GÜNGÖR, DDS, Assoc. Prof. Dr., Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858033
- Sponsor's protocol ID
- AkdenizUıremkapıcı001
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapici I, Gungor AY, Erken Gungor O. Assessment of the impact of Z-Spring appliances and clear aligners on salivary parameters and periodontal health in children: a randomized clinical trial. BMC Oral Health. 2025 Dec 29;25(1):1951. doi: 10.1186/s12903-025-07304-4.
PubMed 41462222Kapicii I, Erken Gungor O, Yildirim K, Atas C, Yilmaz Coban A. Impact of Z-spring appliance and clear aligner therapy on oral microorganisms in children: A clinical trial. Saudi Med J. 2025 Jul;46(7):825-830. doi: 10.15537/smj.2025.46.7.20250264.
PubMed 40628430
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Children's Oral Microflora and Salivary Parameters
- ClinicalTrials.gov ID
- NCT06858033
- Acronym / sponsor ID
- AkdenizUıremkapıcı001
- Conditions
- Anterior Crossbite
- Keywords
- Clear aligner, Labiolingual spring hawley, Oral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ozge GungorUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 5 Mar 2025 (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.
Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients.
Method: A total of 30 pediatric patients aged 7-12 years were treated with a total of 30 appliances including 15 clear aligners (Group A) and 15 labiolingual spring hawleys (Group B). In the clinical examination of the patients, dental caries status was evaluated by DMFT and dft index, periodontal health status was evaluated by probing pocket depth measurements and plaque, gingival and probing bleeding indices. In addition, saliva and dental plaque samples were taken and salivary parameters and microbiologic structure of plaque were analyzed. All these procedures were performed in 2 different time periods for each patient; before and after the treatment. The results were statistically evaluated using SPSS (SPSS Statistics v23.0 for Windows, Chicago, IL, USA).
Detailed description
In the clinical examination of the participants, dental caries status was evaluated by DMFT and dft index, and periodontal health status was evaluated by probing pocket depth measurements; PI, GI, SDI. In addition, saliva and dental plaque samples were taken and salivary parameters (flow rate, pH and buffering capacity) and microbiological structure of plaque were analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner users | Experimental | Device: Clear alignerPatients who were treated with clear aligners were referred to as 'clear aligner users'. |
| Labiolingual spring hawley users | Experimental | Device: Labiolingual spring hawleyPatients who were treated with clear aligners were referred to as 'Labiolingual spring hawle users'. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Dental anterior crossbite
Key exclusion criteria (3 listed)
- Skeletal anterior crossbite
- Systemic disease
- Regular medication use
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 |
|---|---|---|
| Clear alignerThe effects of treatment on periodontal parameters (plaque index, gingival index, bleeding index on probing), salivary parameters (stimulated/unstimulated flow rate, stimulated/unstimulated pH, buffering capacity) and oral microorganism counts (S. mitis, S. salivarius, S. mutans, C. albicans) of children treated with labiolingual spring hawley and clear aligners were investigated. | Device | Clear aligner users |
| Labiolingual spring hawleyThe effects of treatment on periodontal parameters (plaque index, gingival index, bleeding index on probing), salivary parameters (stimulated/unstimulated flow rate, stimulated/unstimulated pH, buffering capacity) and oral microorganism counts (S. mitis, S. salivarius, S. mutans, C. albicans) of children treated with labiolingual spring hawley and clear aligners were investigated. | Device | Labiolingual spring hawley users |
Primary outcome
PIaque index (PI)
Time frame: 3 months
Based on Silness-Löe (1963, 1967) PI values, bacterial plaque and plaque thickness in direct contact with the marginal gingiva are evaluated. The evaluation is made with the Williams-marked University of Michigan 'O' periodontal probe, and PI values are recorded from a total of 4 surfaces of each tooth included in the study, namely mesial, distal, buccal and lingual. The averages of these values are calculated for each patient. The average scores obtained are evaluated in the 0-3 score range. An increase in the calculated scores indicates that periodontal health is negatively affected.
DMFT index
Time frame: 3 months
To determine the DMFT index score, decayed teeth in permanent teeth are indicated as "D", lost teeth extracted due to decay are indicated as "M", and filled teeth are indicated as "F". The DMFT index is calculated by adding the D, M, F values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.
Oral microorganisms count
Time frame: 3 months
S. mitis, S. salivarius, S.mutans, C. albicans (cfu/ml)
Gingival index (GI)
Time frame: 3 months
The degree of gingivitis is assessed using the Silness-Löe (1963, 1967) GI. The average of the measurements taken from four sides of the tooth determines the GI score of the tooth, and the average of the measurements of all teeth determines the individual's gingival index score. The scores obtained are evaluated in the range of 0-3. An increase in the calculated scores indicates that periodontal health is negatively affected.
Bleeding on probing index (BOP)
Time frame: 3 months
In order to determine the inflammatory status of the pocket base and pocket epithelium, a score is given as positive (+) or negative (-) according to whether there is bleeding in the sulcus 20 seconds after the pocket depth measurement from a total of 4 surfaces of the teeth, mesial, distal, buccal and lingual. BOP is calculated as a score by dividing the number of bleeding teeth by the total number of tooth surfaces in each patient. An increase in the calculated scores indicates that periodontal health is negatively affected.
dft index
Time frame: 3 months
The dft Index is the calculated form of the DMFT index for primary teeth. When calculating the dft group index, missing teeth are not included in the calculation. Because it is difficult to diagnose the reason for the loss of primary teeth and there is a high probability of error. For this reason, the number of decayed and filled teeth is calculated during the examination. Decayed teeth are indicated with "d" and filled teeth with "f". The dft index is calculated by adding the d and f values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.
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 5 Mar 2025.
- Derived from this study: PubMed 41462222Kapici I, Gungor AY, Erken Gungor O. Assessment of the impact of Z-Spring appliances and clear aligners on salivary parameters and periodontal health in children: a randomized clinical trial. BMC Oral Health. 2025 Dec 29;25(1):1951. doi: 10.1186/s12903-025-07304-4.
- Derived from this study: PubMed 40628430Kapicii I, Erken Gungor O, Yildirim K, Atas C, Yilmaz Coban A. Impact of Z-spring appliance and clear aligner therapy on oral microorganisms in children: A clinical trial. Saudi Med J. 2025 Jul;46(7):825-830. doi: 10.15537/smj.2025.46.7.20250264.
- 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.
Özge GÜNGÖR, DDS, Assoc. Prof. Dr. principal investigator
Akdeniz 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 Clear aligner and Labiolingual spring hawley in people with Anterior Crossbite, run by Ozge Gungor 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 1 inclusion and 3 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 5 Mar 2025. 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?
PIaque index (PI) (time frame: 3 months). The study lists 6 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 NCT06858033, which also lists 2 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 5 Mar 2025.