Gingival BiotypeNCT07349056
Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation
An observational study of Gingival Biotype and Gingival Phenotype, run by Trakya University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn how the health and thickness of the gums and supporting bone around the teeth change over 6 months in adults having jaw surgery to correct the bite. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingival Biotype, Gingival Phenotype, Buccal Bone Thickness
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 23 Feb 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients referred for orthognathic surgery to the Department of Oral and Maxillofacial Surgery at Kocaeli Health and Technology University and subsequently evaluated at the Department of Periodontology at Trakya University
Who may be able to join
- Adults aged ≥18 years.
- Presence of a Class III molar relationship of any severity at baseline.
- Presence of a Class II molar relationship of any severity at baseline.
- Presence of transverse arch discrepancies.
- Presence of vertical maxillary excess.
- Presence of maxillary and/or mandibular asymmetry.
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- Presence of anterior open bite.
- Full permanent dentition up to the first molars, with no supernumerary teeth and no agenesis (congenital absence) of teeth up to the first molars.
- No previous orthodontic treatment.
- No history of tooth extraction other than second or third molars.
- Availability of complete baseline and end-of-follow-up periodontal parameters and phenotype records suitable for evaluation.
- Healthy periodontium with no signs of gingival hypertrophy.
- No systemic disease history or medication use that could affect gingival/periodontal conditions.
Who cannot join
- Patients planned for orthodontic camouflage treatment with fixed appliances for Class II/Class III correction instead of orthognathic surgery.
- History of interproximal enamel reduction (interproximal stripping).
- Presence of dental implants.
- Age < 18 years.
- Pregnant or breastfeeding individuals.
- Any systemic condition contraindicates orthognathic surgery.
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- Psychiatric disorders.
- Syndromic conditions.
- History of previous orthognathic surgery.
- Refusal to sign the informed consent form.
- Individuals belonging to a vulnerable population.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Trakya University Faculty of Dentistry
Edirne
Ece Açıkgöz- Alparslan, +902842364551, eceacikgoz@trakya.edu.tr
Gizem Kantarcı Arda, +902842364551
- Recruiting
Kocaeli Health and Technology University Faculty of Dentistry
Kocaeli
Muhammed Göksel Tımarcıoğlu, +908502284141, info@kocaelisaglik.edu.tr
About this study
Official title: Evaluation of Periodontal Phenotype Following Orthognathic Surgery: A Two-Center, 6-Month Prospective Clinical and CBCT Study
The goal of this observational study is to learn how the health and thickness of the gums and supporting bone around the teeth change over 6 months in adults having jaw surgery to correct the bite. The main questions it aims to answer are:
- Do gum and tooth-support measurements change from before surgery to 1, 3, and 6 months after surgery?
- Do CT scan-based measurements of the tooth-supporting bone change over the same time period?
Participants will:
- Have a gum check-up (periodontal examination) before surgery and at 1, 3, and 6 months after surgery.
- Have CT scan-based measurements (CBCT) taken at the same time points for study assessment.
Read the detailed description
This two-center prospective observational cohort study will enroll adult patients who are scheduled to undergo orthognathic surgery according to standard clinical indications. Orthognathic surgeries will be performed at Kocaeli Health and Technology University, while periodontal clinical examinations and CBCT-based assessments will be conducted at Trakya University. Participants will be evaluated at baseline (preoperatively) and at 1, 3, and 6 months after surgery. Clinical periodontal assessments will include predefined periodontal phenotype-related parameters recorded using a standardized protocol. CBCT datasets will be obtained and analyzed using a standardized measurement protocol to assess buccal alveolar bone-related parameters and the presence of dehiscence/fenestration where applicable. To minimize assessment bias, CBCT images will be coded and evaluated by an independent assessor blinded to surgical details and group classification, and clinical periodontal examinations will be performed by an examiner blinded to the surgical procedure details.
- Conditions
- Gingival Biotype, Gingival Phenotype, Buccal Bone Thickness, Recession, Gingival, Dental Surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Mandibular setback < 6 mm) | Not described | |
| Group B (Mandibular setback ≥ 6 mm) | Not described | |
| Group C (Mandibular advancement < 6 mm) | Not described | |
| Group D (Mandibular advancement ≥ 6 mm) | Not described | |
| Group E (Maxillary advancement < 6 mm + maxillary impaction) | Not described | |
| Group F (Maxillary advancement < 6 mm + maxillary downgrafting) | Not described | |
| Group G (Maxillary advancement < 6 mm + no impaction/downgrafting) | Not described | |
| Group H (Maxillary advancement ≥ 6 mm + maxillary impaction) | Not described | |
| Group I (Maxillary advancement ≥ 6 mm + maxillary downgrafting) | Not described | |
| Group J (Maxillary advancement ≥ 6 mm + no impaction/downgrafting) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in width of keratinized gingiva (mm)
Width of keratinized gingiva is measured as the distance from the gingival margin to the mucogingival junction, recorded in mm.
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Change in gingival thickness phenotype (thin vs thick)
Gingival thickness is assessed with a periodontal probe by the probe-transparency method and categorized as thin (≤1 mm; probe visible) or thick (>1 mm; probe not visible)
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Change in buccal cortical bone thickness on CBCT (mm)
Buccal cortical bone thickness is measured on CBCT as the horizontal distance from the deepest point of the buccal marginal bone curvature (A) to the CEJ, and additionally at 4 mm apical to A and at the apex level, as defined in the protocol
Measured: Baseline (preoperative) and postoperative follow-up CBCT records were obtained during routine controls (planned at 6 months).
Secondary outcomes (8)
Probing pocket depth (mm)
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Bleeding on probing (0/1)
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival Index (0-3)
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Plaque Index (0-3)
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Papilla loss classification (Nordland & Tarnow)
Measured: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival recession (mm)
Measured: Baseline and postoperative 1, 3, 6 months.
Fenestration/dehiscence presence on CBCT (yes/no) (and/or counts)
Measured: Baseline and postoperative 6 months.
Clinical attachment loss (mm)
Measured: Baseline and postoperative 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start23 Feb 2026
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival BiotypeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Responsible party
- Principal investigator, Ece AÇIKGÖZ ALPARSLAN, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349056
- Sponsor's protocol ID
- 2522A04
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data containing personal health information will not be shared due to privacy and confidentiality requirements, as well as ethical restrictions and applicable standards
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Periodontal Phenotype Following Orthognathic Surgery: A Two-Center, 6-Month Prospective Clinical and CBCT Study
- ClinicalTrials.gov ID
- NCT07349056
- Acronym / sponsor ID
- 2522A04
- Conditions
- Gingival Biotype, Gingival Phenotype, Buccal Bone Thickness, Recession, Gingival, Dental Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 16 Jan 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.
The goal of this observational study is to learn how the health and thickness of the gums and supporting bone around the teeth change over 6 months in adults having jaw surgery to correct the bite. The main questions it aims to answer are:
- Do gum and tooth-support measurements change from before surgery to 1, 3, and 6 months after surgery?
- Do CT scan-based measurements of the tooth-supporting bone change over the same time period?
Participants will:
- Have a gum check-up (periodontal examination) before surgery and at 1, 3, and 6 months after surgery.
- Have CT scan-based measurements (CBCT) taken at the same time points for study assessment.
Detailed description
This two-center prospective observational cohort study will enroll adult patients who are scheduled to undergo orthognathic surgery according to standard clinical indications. Orthognathic surgeries will be performed at Kocaeli Health and Technology University, while periodontal clinical examinations and CBCT-based assessments will be conducted at Trakya University. Participants will be evaluated at baseline (preoperatively) and at 1, 3, and 6 months after surgery. Clinical periodontal assessments will include predefined periodontal phenotype-related parameters recorded using a standardized protocol. CBCT datasets will be obtained and analyzed using a standardized measurement protocol to assess buccal alveolar bone-related parameters and the presence of dehiscence/fenestration where applicable. To minimize assessment bias, CBCT images will be coded and evaluated by an independent assessor blinded to surgical details and group classification, and clinical periodontal examinations will be performed by an examiner blinded to the surgical procedure details.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group A (Mandibular setback < 6 mm) | – | – |
| Group B (Mandibular setback ≥ 6 mm) | – | – |
| Group C (Mandibular advancement < 6 mm) | – | – |
| Group D (Mandibular advancement ≥ 6 mm) | – | – |
| Group E (Maxillary advancement < 6 mm + maxillary impaction) | – | – |
| Group F (Maxillary advancement < 6 mm + maxillary downgrafting) | – | – |
| Group G (Maxillary advancement < 6 mm + no impaction/downgrafting) | – | – |
| Group H (Maxillary advancement ≥ 6 mm + maxillary impaction) | – | – |
| Group I (Maxillary advancement ≥ 6 mm + maxillary downgrafting) | – | – |
| Group J (Maxillary advancement ≥ 6 mm + no impaction/downgrafting) | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred for orthognathic surgery to the Department of Oral and Maxillofacial Surgery at Kocaeli Health and Technology University and subsequently evaluated at the Department of Periodontology at Trakya University
Key inclusion criteria (13 listed)
- Adults aged ≥18 years.
- Presence of a Class III molar relationship of any severity at baseline.
- Presence of a Class II molar relationship of any severity at baseline.
- Presence of transverse arch discrepancies.
- Presence of vertical maxillary excess.
Key exclusion criteria (11 listed)
- Patients planned for orthodontic camouflage treatment with fixed appliances for Class II/Class III correction instead of orthognathic surgery.
- History of interproximal enamel reduction (interproximal stripping).
- Presence of dental implants.
- Age < 18 years.
- Pregnant or breastfeeding individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in width of keratinized gingiva (mm)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Width of keratinized gingiva is measured as the distance from the gingival margin to the mucogingival junction, recorded in mm.
Change in gingival thickness phenotype (thin vs thick)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival thickness is assessed with a periodontal probe by the probe-transparency method and categorized as thin (≤1 mm; probe visible) or thick (>1 mm; probe not visible)
Change in buccal cortical bone thickness on CBCT (mm)
Time frame: Baseline (preoperative) and postoperative follow-up CBCT records were obtained during routine controls (planned at 6 months).
Buccal cortical bone thickness is measured on CBCT as the horizontal distance from the deepest point of the buccal marginal bone curvature (A) to the CEJ, and additionally at 4 mm apical to A and at the apex level, as defined in the protocol
8 secondary outcomes
Probing pocket depth (mm)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Bleeding on probing (0/1)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival Index (0-3)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Plaque Index (0-3)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Papilla loss classification (Nordland & Tarnow)
Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival recession (mm)
Time frame: Baseline and postoperative 1, 3, 6 months.
Fenestration/dehiscence presence on CBCT (yes/no) (and/or counts)
Time frame: Baseline and postoperative 6 months.
Clinical attachment loss (mm)
Time frame: Baseline and postoperative 1, 3, 6 months
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 8 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data containing personal health information will not be shared due to privacy and confidentiality requirements, as well as ethical restrictions and applicable standards
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Biotype and Gingival Phenotype, run by Trakya University at 2 sites 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 13 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Ece Açıkgöz-Alparslan (+902842364551, eceacikgoz@trakya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in width of keratinized gingiva (mm) (time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.). The study lists 3 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 8 Jun 2026.