MalocclusionNCT07802249
Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
An observational study of Malocclusion and Periodontal Diseases, run by Ravan Mammadov at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will compare the effects of fixed orthodontic appliances and clear aligners on periodontal health during the initial three months of orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion, Periodontal Diseases, Periodontal Health
- What is being tested?
- Fixed Orthodontic Appliance and Clear Aligner Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2026to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Systemically healthy adults aged 18 years and older who are periodontally healthy or have gingivitis and have an indication for orthodontic treatment without tooth extraction will be recruited from patients presenting to the Altınbaş University Dental Hospital.
Who may be able to join
- Individuals aged 18 years or older
- Systemically healthy individuals
- Periodontally healthy individuals or those diagnosed with gingivitis
- Probing pocket depth of 3 mm or less, with no clinical attachment loss and no reduced periodontium
- Indication for orthodontic treatment
- Orthodontic treatment planned without tooth extraction
- Less than 5 mm of dental crowding in both the maxillary and mandibular arches, as determined by Hayes-Nance arch-length discrepancy analysis
Who cannot join
- Pregnant or breastfeeding individuals
- Individuals with systemic disease that could influence periodontal status
- Current use of cigarettes or other tobacco products
- Individuals with a history of initial periodontal therapy within the preceding six months
- Individuals who had previously undergone orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Altınbaş University Dental Hospital
Istanbul, Bakirköy, 34147
About this study
Official title: Comparative Effects of Fixed Orthodontic Appliances and Clear Aligners on Periodontal Health in Adults: A Prospective Observational Study
This prospective observational study will compare the effects of fixed orthodontic appliances and clear aligners on periodontal health during the initial three months of orthodontic treatment. Thirty systemically healthy adults will be included in two groups of fifteen according to the orthodontic treatment modality received. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters, including plaque accumulation, gingival inflammation, bleeding on probing, probing pocket depth, and clinical attachment level, will be assessed at baseline, following periodontal treatment, and at the third month of orthodontic therapy. Patient-reported outcomes related to oral health-related quality of life, gingival symptoms, and oral hygiene difficulty will also be evaluated. The study aims to determine whether periodontal and patient-reported outcomes differ between fixed orthodontic appliances and clear aligners during the early phase of orthodontic treatment.
- Conditions
- Malocclusion, Periodontal Diseases, Periodontal Health
- Being tested
- Fixed Orthodontic Appliance, Clear Aligner Therapy
- Keywords
- Periodontal Health, Clear Aligners, Fixed Orthodontic Appliances, Dental Biofilm, Oral Health Impact Profile-14, Visual Analog Scale
- Medical subject headings
- Malocclusion, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Orthodontic ApplianceDevice
Bracket-and-archwire system used for orthodontic tooth movement.
Clear Aligner TherapyDevice
Removable thermoplastic aligners used for orthodontic tooth movement.
| Study group | Role | What they receive |
|---|---|---|
| CA Group (Clear Aligner Therapy) | Participants who will receive clear aligner therapy for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy. Receives: Device: Clear Aligner Therapy | |
| FOA Group (Fixed Orthodontic Appliances) | Participants who will receive fixed orthodontic appliances (brackets and archwires) for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy. Receives: Device: Fixed Orthodontic Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Full Mouth Plaque Score (FMPS) will be calculated as the percentage of tooth surfaces exhibiting visible plaque. The scale ranges from 0% to 100%, with higher scores indicating greater plaque accumulation and poorer plaque control.
Measured: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Bleeding on Probing (BoP) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Bleeding on probing (BoP) will be assessed at six sites per tooth using a periodontal probe. Bleeding occurring within 30 seconds after probing will be recorded as positive. The BoP score will be calculated as the percentage of bleeding-positive sites relative to the total number of sites examined, ranging from 0% to 100%, with higher scores indicating greater gingival inflammation.
Measured: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Gingival Index (GI) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Gingival Index (GI) will be assessed according to the Löe and Silness criteria at six sites per tooth. The scale ranges from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe gingival inflammation with a tendency for spontaneous bleeding. Higher scores indicate worse gingival inflammation.
Measured: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Probing Pocket Depth (PPD) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Probing Pocket Depth (PPD) will be measured at six sites per tooth using a UNC-15 periodontal probe. PPD will be recorded in millimeters as the distance from the gingival margin to the base of the periodontal sulcus or pocket. Higher values indicate greater probing depth.
Measured: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Clinical Attachment Level (CAL) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Clinical Attachment Level (CAL) will be measured at six sites per tooth using a periodontal probe and recorded in millimeters as the distance from the cementoenamel junction to the base of the periodontal sulcus or pocket. Higher values indicate greater attachment loss.
Measured: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Secondary outcomes (2)
Change in Oral Health Impact Profile-14 (OHIP-14) Score Between Fixed Orthodontic Appliance and Clear Aligner Groups
Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14). The questionnaire includes 14 items scored on a 5-point Likert scale from 0 (never) to 4 (very often), producing a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life.
Measured: Baseline (T0) and 3 months after orthodontic treatment initiation (T2).
Visual Analog Scale (VAS) Scores for Gingival Symptoms and Oral Hygiene Difficulty Between Fixed Orthodontic Appliance and Clear Aligner Groups
Patient-reported gingival symptoms and oral hygiene difficulty will be assessed using an 8-item Visual Analog Scale (VAS). Each item will be scored from 0 to 10. Higher scores will indicate greater symptom severity or greater oral hygiene difficulty for the symptom and difficulty items, whereas higher scores on the gingival health satisfaction item will indicate greater satisfaction.
Measured: At 3 months after orthodontic treatment initiation (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start11 Sep 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ravan Mammadov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ravan Mammadov, Altinbas University
- Investigators
- Ravan Mammadov, Principal investigator, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802249
- Sponsor's protocol ID
- FOACA-2026-01
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Fixed Orthodontic Appliances and Clear Aligners on Periodontal Health in Adults: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07802249
- Acronym / sponsor ID
- FOACA-2026-01
- Conditions
- Malocclusion, Periodontal Diseases, Periodontal Health
- Keywords
- Periodontal Health, Clear Aligners, Fixed Orthodontic Appliances, Dental Biofilm, Oral Health Impact Profile-14, Visual Analog Scale
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ravan MammadovUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 3 Sep 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.
This prospective observational study will compare the effects of fixed orthodontic appliances and clear aligners on periodontal health during the initial three months of orthodontic treatment. Thirty systemically healthy adults will be included in two groups of fifteen according to the orthodontic treatment modality received. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters, including plaque accumulation, gingival inflammation, bleeding on probing, probing pocket depth, and clinical attachment level, will be assessed at baseline, following periodontal treatment, and at the third month of orthodontic therapy. Patient-reported outcomes related to oral health-related quality of life, gingival symptoms, and oral hygiene difficulty will also be evaluated. The study aims to determine whether periodontal and patient-reported outcomes differ between fixed orthodontic appliances and clear aligners during the early phase of orthodontic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA Group (Clear Aligner Therapy) | – | Device: Clear Aligner TherapyParticipants who will receive clear aligner therapy for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy. |
| FOA Group (Fixed Orthodontic Appliances) | – | Device: Fixed Orthodontic ApplianceParticipants who will receive fixed orthodontic appliances (brackets and archwires) for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy adults aged 18 years and older who are periodontally healthy or have gingivitis and have an indication for orthodontic treatment without tooth extraction will be recruited from patients presenting to the Altınbaş University Dental Hospital.
Key inclusion criteria (7 listed)
- Individuals aged 18 years or older
- Systemically healthy individuals
- Periodontally healthy individuals or those diagnosed with gingivitis
- Probing pocket depth of 3 mm or less, with no clinical attachment loss and no reduced periodontium
- Indication for orthodontic treatment
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding individuals
- Individuals with systemic disease that could influence periodontal status
- Current use of cigarettes or other tobacco products
- Individuals with a history of initial periodontal therapy within the preceding six months
- Individuals who had previously undergone orthodontic treatment
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 |
|---|---|---|
| Fixed Orthodontic ApplianceBracket-and-archwire system used for orthodontic tooth movement. | Device | FOA Group (Fixed Orthodontic Appliances) |
| Clear Aligner TherapyRemovable thermoplastic aligners used for orthodontic tooth movement. | Device | CA Group (Clear Aligner Therapy) |
Primary outcome
Change in Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Full Mouth Plaque Score (FMPS) will be calculated as the percentage of tooth surfaces exhibiting visible plaque. The scale ranges from 0% to 100%, with higher scores indicating greater plaque accumulation and poorer plaque control.
Change in Bleeding on Probing (BoP) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Bleeding on probing (BoP) will be assessed at six sites per tooth using a periodontal probe. Bleeding occurring within 30 seconds after probing will be recorded as positive. The BoP score will be calculated as the percentage of bleeding-positive sites relative to the total number of sites examined, ranging from 0% to 100%, with higher scores indicating greater gingival inflammation.
Change in Gingival Index (GI) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Gingival Index (GI) will be assessed according to the Löe and Silness criteria at six sites per tooth. The scale ranges from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe gingival inflammation with a tendency for spontaneous bleeding. Higher scores indicate worse gingival inflammation.
Change in Probing Pocket Depth (PPD) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Probing Pocket Depth (PPD) will be measured at six sites per tooth using a UNC-15 periodontal probe. PPD will be recorded in millimeters as the distance from the gingival margin to the base of the periodontal sulcus or pocket. Higher values indicate greater probing depth.
Change in Clinical Attachment Level (CAL) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Clinical Attachment Level (CAL) will be measured at six sites per tooth using a periodontal probe and recorded in millimeters as the distance from the cementoenamel junction to the base of the periodontal sulcus or pocket. Higher values indicate greater attachment loss.
2 secondary outcomes
Change in Oral Health Impact Profile-14 (OHIP-14) Score Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: Baseline (T0) and 3 months after orthodontic treatment initiation (T2).
Visual Analog Scale (VAS) Scores for Gingival Symptoms and Oral Hygiene Difficulty Between Fixed Orthodontic Appliance and Clear Aligner Groups
Time frame: At 3 months after orthodontic treatment initiation (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and privacy.
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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.
Ravan Mammadov principal investigator
Altinbas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Periodontal Diseases, run by Ravan Mammadov 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 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
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 Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups (time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).). The study lists 5 primary outcomes in all. 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 14 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.