Guided Bone RegenerationNCT07918118
Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
An observational study of Guided Bone Regeneration, run by Fuming He.
Trial summary
Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for reconstructing hard tissue defects in implant placement in the anterior esthetic zone. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2026to 30 Nov 2027
- How long will I take part?
- 6 Months
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From the date of ethics approval to Nov 2027, all patients who meet the inclusion criteria and who undergo implant placement in the maxillary anterior region with simultaneous guided bone regeneration (GBR) at the Stomatology Hospital, Zhejiang University School of Medicine.
Who may be able to join
- Aged 18 years or older
- A single tooth in the maxillary anterior region is to be implanted and restored with a single crown
- A single implant-supported prosthesis in the maxillary anterior region
- Severe bone deficiency in the maxillary anterior region, with residual alveolar bone height of 4-6 mm
- The patient requests an implant-supported fixed prosthesis
- The patient is able to understand and actively cooperate with the diagnostic and treatment process, and has signed the informed consent form
- Good oral hygiene status
Who cannot join
- Patients who cannot tolerate implant surgery (due to systemic diseases such as heart disease, hypertension, etc., or a history of long-term medication use)
- Pregnancy or gestation
- Daily smoking of more than 10 cigarettes
- Presence of physical defects that may affect implant surgery
- Patients with immune deficiency, including HIV-infected patients
- Local inflammation, including untreated periodontitis
Show all 12Show fewer
- History of radiotherapy or chemotherapy to the head and neck region within the past year, or a history of intravenous bisphosphonate use
- Severe bruxism or clenching habits
- Poor oral hygiene or poor compliance
- Patients who have previously undergone bone augmentation or soft-tissue augmentation at the implant site
- Presence of benign or malignant tumors in the implant area
- Bone defects such as severe osteoporosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Gingival Phenotype on Soft and Hard Tissues Dimensional Changes Following Guided Bone Regeneration in the Maxillary Anterior Region
Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for reconstructing hard tissue defects in implant placement in the anterior esthetic zone. According to the initial bone defect morphology and soft tissue morphology (e.g., the "gingival biotype") in the maxillary anterior esthetic zone, the clinical outcomes of bone regeneration after implantation can be improved by adjusting the direction of implant placement. Currently, few published studies have investigated the effects of gingival biotype on GBR outcomes; sample sizes and comprehensive analyses are insufficient, and some results are contradictory.2. Research objective: Exploring the influence of gingival biotype on soft and hard tissue dimensional changes following guided bone regeneration in the maxillary anterior region. This study takes gingival biotype as the primary research factor and conducts a prospective cohort comparison between two groups, contrasting the effects of thin versus thick gingival biotypes on soft and hard tissue stability following GBR in the maxillary anterior area. 3. Study design and methods: Design type: prospective clinical study. Study duration: 1 year. Start time: From the date of adoption of ethics. End time: 2027. For all included patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 3 and 6 months postoperatively.
Read the detailed description
Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for reconstructing hard tissue defects in implant placement in the anterior esthetic zone. According to the initial bone defect morphology and soft tissue morphology (e.g., the "gingival biotype") in the maxillary anterior esthetic zone, the clinical outcomes of bone regeneration after implantation can be improved by adjusting the direction of implant placement. Currently, few published studies have investigated the effects of gingival biotype on GBR outcomes; sample sizes and comprehensive analyses are insufficient, and some results are contradictory.2. Research objective: Exploring the influence of gingival biotype on soft and hard tissue dimensional changes following guided bone regeneration in the maxillary anterior region. This study takes gingival biotype as the primary research factor and conducts a prospective cohort comparison between two groups, contrasting the effects of thin versus thick gingival biotypes on soft and hard tissue stability following GBR in the maxillary anterior area. 3. Study design and methods: Design type: prospective clinical study. Study duration: 1 year. Start time: From the date of adoption of ethics. End time: Nov 2027. From the date of ethics approval to Nov 2027, all patients who meet the inclusion criteria and who undergo implant placement in the maxillary anterior region with simultaneous guided bone regeneration at the Stomatology Hospital, Zhejiang University School of Medicine will be screened. Their basic information (including questionnaire completion), treatment procedures, and imaging data will be collected, and they will undergo a comprehensive clinical oral examination. For all patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 3 and 6 months postoperatively. Digital imaging and communications in medicine (DICOM) data from each CBCT scan will be used for three-dimensional volumetric reconstruction and analysis with 3D Slicer and 3Shape Implant Studio. Preoperatively, gingival biotype (thick vs. thin) will be assessed using intraoral scan data. Immediately postoperatively, the thickness and surface area of the graft material placed during GBR and gingival thickness will be assessed using CBCT and intraoral scanning. At the 6-month postoperative follow-up visits, gingival thickness, and facial hard tissue thickness (facial bone wall and the thickness and surface area of the GBR graft material) will be assessed. The collected data will be analyzed to evaluate the effect of the initial gingival biotype on postoperative osteogenic outcomes after GBR in patients with missing anterior teeth.
- Conditions
- Guided Bone Regeneration
- Keywords
- guided bone regeneration, maxillary anterior region, gingival biotype, bone augmentation, soft tissue stability
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 |
|---|---|---|
| Thin gingival biotype group | Not described | |
| Thick gingival biotype group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone augmentation
The cone beam computed tomography (CBCT) data from the two time points (on the day of the initial consultation (T0), and six months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. V2 (volumes of the 6-month bone increment) can be accessed from the properties menu.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (4)
Bone resorption
The cone beam computed tomography (CBCT) data from the three time points (on the day of the initial consultation (T0), immediately after surgery (T1) and six months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T1 and T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. V1 (volumes of the immediate bone increment) and V2 (volumes of the 6-month bone increment) can be accessed from the properties menu. The resorption rate of bone increment, denoted as RV, can be calculated by utilizing the formula (V1 -V2)/V1.
Measured: From enrollment to the end of treatment at 6 months
Soft tissue healing
Soft tissue healing condition recorded by oral scanning and photography in 2 weeks before and 2 weeks after surgery and 6 months after surgery.
Measured: From enrollment to the end of treatment at 6 months
Bone height change
The STL files of the preoperative bone defect region, immediate postoperative augmented bone, and bone at 6 months postoperatively were imported into the E-3D implant design software with a unified coordinate system. These files were then registered to the CBCT datasets, and the implant site was planned. Using the long axis of the virtually designed implant, an inspection plane was created in the buccolingual direction, from which two-dimensional measurements were acquired. The STL models of bone contours at the three time points were visualized in 2D within the E-3D software. The linear distance between T0 and T2 was recorded as the augmented bone height (H1), and the linear distance between T1 and T2 was recorded as the bone height after six months of healing (H2). The difference between H1 and H2 represented the bone height resorption over the six-month healing period.
Measured: From enrollment to the end of treatment at 6 months
Patient satisfaction
postoperative satisfaction through VAS assessment
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start3 Nov 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies 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)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fuming He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuming He, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918118
- Sponsor's protocol ID
- DHZhejiangU-2024-084
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gingival Phenotype on Soft and Hard Tissues Dimensional Changes Following Guided Bone Regeneration in the Maxillary Anterior Region
- ClinicalTrials.gov ID
- NCT07918118
- Acronym / sponsor ID
- DHZhejiangU-2024-084
- Conditions
- Guided Bone Regeneration
- Keywords
- guided bone regeneration, maxillary anterior region, gingival biotype, bone augmentation, soft tissue stability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fuming HeUniversity, hospital or other
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 5 Nov 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.
Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for reconstructing hard tissue defects in implant placement in the anterior esthetic zone. According to the initial bone defect morphology and soft tissue morphology (e.g., the "gingival biotype") in the maxillary anterior esthetic zone, the clinical outcomes of bone regeneration after implantation can be improved by adjusting the direction of implant placement. Currently, few published studies have investigated the effects of gingival biotype on GBR outcomes; sample sizes and comprehensive analyses are insufficient, and some results are contradictory.2. Research objective: Exploring the influence of gingival biotype on soft and hard tissue dimensional changes following guided bone regeneration in the maxillary anterior region. This study takes gingival biotype as the primary research factor and conducts a prospective cohort comparison between two groups, contrasting the effects of thin versus thick gingival biotypes on soft and hard tissue stability following GBR in the maxillary anterior area. 3. Study design and methods: Design type: prospective clinical study. Study duration: 1 year. Start time: From the date of adoption of ethics. End time: 2027. For all included patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 3 and 6 months postoperatively.
Detailed description
Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for reconstructing hard tissue defects in implant placement in the anterior esthetic zone. According to the initial bone defect morphology and soft tissue morphology (e.g., the "gingival biotype") in the maxillary anterior esthetic zone, the clinical outcomes of bone regeneration after implantation can be improved by adjusting the direction of implant placement. Currently, few published studies have investigated the effects of gingival biotype on GBR outcomes; sample sizes and comprehensive analyses are insufficient, and some results are contradictory.2. Research objective: Exploring the influence of gingival biotype on soft and hard tissue dimensional changes following guided bone regeneration in the maxillary anterior region. This study takes gingival biotype as the primary research factor and conducts a prospective cohort comparison between two groups, contrasting the effects of thin versus thick gingival biotypes on soft and hard tissue stability following GBR in the maxillary anterior area. 3. Study design and methods: Design type: prospective clinical study. Study duration: 1 year. Start time: From the date of adoption of ethics. End time: Nov 2027. From the date of ethics approval to Nov 2027, all patients who meet the inclusion criteria and who undergo implant placement in the maxillary anterior region with simultaneous guided bone regeneration at the Stomatology Hospital, Zhejiang University School of Medicine will be screened. Their basic information (including questionnaire completion), treatment procedures, and imaging data will be collected, and they will undergo a comprehensive clinical oral examination. For all patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 3 and 6 months postoperatively. Digital imaging and communications in medicine (DICOM) data from each CBCT scan will be used for three-dimensional volumetric reconstruction and analysis with 3D Slicer and 3Shape Implant Studio. Preoperatively, gingival biotype (thick vs. thin) will be assessed using intraoral scan data. Immediately postoperatively, the thickness and surface area of the graft material placed during GBR and gingival thickness will be assessed using CBCT and intraoral scanning. At the 6-month postoperative follow-up visits, gingival thickness, and facial hard tissue thickness (facial bone wall and the thickness and surface area of the GBR graft material) will be assessed. The collected data will be analyzed to evaluate the effect of the initial gingival biotype on postoperative osteogenic outcomes after GBR in patients with missing anterior teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin gingival biotype group | – | – |
| Thick gingival biotype group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From the date of ethics approval to Nov 2027, all patients who meet the inclusion criteria and who undergo implant placement in the maxillary anterior region with simultaneous guided bone regeneration (GBR) at the Stomatology Hospital, Zhejiang University School of Medicine.
Key inclusion criteria (7 listed)
- Aged 18 years or older
- A single tooth in the maxillary anterior region is to be implanted and restored with a single crown
- A single implant-supported prosthesis in the maxillary anterior region
- Severe bone deficiency in the maxillary anterior region, with residual alveolar bone height of 4-6 mm
- The patient requests an implant-supported fixed prosthesis
Key exclusion criteria (12 listed)
- Patients who cannot tolerate implant surgery (due to systemic diseases such as heart disease, hypertension, etc., or a history of long-term medication use)
- Pregnancy or gestation
- Daily smoking of more than 10 cigarettes
- Presence of physical defects that may affect implant surgery
- Patients with immune deficiency, including HIV-infected patients
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
Bone augmentation
Time frame: From enrollment to the end of treatment at 6 months
The cone beam computed tomography (CBCT) data from the two time points (on the day of the initial consultation (T0), and six months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. V2 (volumes of the 6-month bone increment) can be accessed from the properties menu.
4 secondary outcomes
Bone resorption
Time frame: From enrollment to the end of treatment at 6 months
Soft tissue healing
Time frame: From enrollment to the end of treatment at 6 months
Bone height change
Time frame: From enrollment to the end of treatment at 6 months
Patient satisfaction
Time frame: From enrollment to the end of treatment at 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 5 Nov 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Guided Bone Regeneration, run by Fuming He.
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 12 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Fuming He (+8613516817697, hfm@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone augmentation (time frame: From enrollment to the end of treatment at 6 months). 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 5 Nov 2026.