Edentulous Alveolar Ridge In MandibleNCT07088172
Clinical Effects of Keratinized Mucosa Augmentation Around Dental Implant With Free Gingival Graft in Different Surgical Timing at Mandibular Posterior Sites
A study testing free gingival grafts during the second stage of implant surgery and free gingival grafts prior to the implantaion in people with Edentulous Alveolar Ridge In Mandible, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study aims to compare clinical outcomes and tissue stability at implant sites in the mandibular posterior region with insufficient buccal keratinized gingiva. It will assess the use of free gingival grafts either before or during the second stage of implant surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge In Mandible
- What is being tested?
- free gingival grafts during the second stage of implant surgery and free gingival grafts prior to the implantaion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2024to Jan 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years, gender unrestricted;
- partially edentulous in the mandible posterior area, planned for implant-supported fixed restoration;
- Buccal keratinized mucosa width at the implant site is less than 2mm, with the transplantation area not exceeding 2 teeth;
- No soft tissue augmentation performed at the site prior to surgery;
- Overall health is good, with no systemic diseases that may affect bone metabolism or wound healing;
- Good periodontal condition, no progressive alveolar bone resorption, no periodontal abscess;
- Smoking ≤ 10 cigarettes per day.
Who cannot join
- Uncontrolled metabolic diseases;
- Severe periodontal disease, with unstable periodontal condition;
- Smoking > 10 cigarettes per day;
- Unwilling to participate in the follow-up of this study;
- Other conditions that do not meet the requirements for implant treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Misi Si, +86 18605712858, misi_si@zju.edu.cn
About this study
This study aims to compare clinical outcomes and tissue stability at implant sites in the mandibular posterior region with insufficient buccal keratinized gingiva. It will assess the use of free gingival grafts either before or during the second stage of implant surgery.
Read the detailed description
To compare the clinical outcomes and the differences in hard and soft tissue stability at implant sites with insufficient buccal keratinized gingiva in the mandibular posterior region, where free gingival grafts are applied either before implant surgery or concurrently during the second stage of implant surgery.
- Conditions
- Edentulous Alveolar Ridge In Mandible
- Being tested
- free gingival grafts during the second stage of implant surgery, free gingival grafts prior to the implantaion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free gingival grafts during the second stage of implant surgeryProcedure or surgery
Free gingival graft surgery performed simultaneously with implant stage II, followed by upper restoration 6-8 weeks later.
free gingival grafts prior to the implantaionProcedure or surgery
Free gingival graft surgery performed 6-8 weeks before implant placement
| Study group | Role | What they receive |
|---|---|---|
| free gingival grafting during the second stage of implant surgery | Experimental | Free gingival graft surgery performed simultaneously with the second stage of the implant surgery, followed by the restoration 6-8 weeks later. Receives: Procedure: free gingival grafts during the second stage of implant surgery |
| free gingival grafts prior to the implantation | Other | Free gingival graft surgery is performed 6-8 weeks before implant placement Receives: Procedure: free gingival grafts prior to the implantaion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of Keratinized Mucosa, KMW
Measured: Preoperative\Immediate postoperative\2 months postoperative\6 months postoperative
Secondary outcomes (7)
Thickness of Keratinized Mucosa, KMT
Measured: Preoperative\ Immediate postoperative\2 months postoperative\6 months postoperative
Postoperative Discomfort
Visual Analog Scale
Measured: follow-up time point(at least 6 months after restoration)
Plaque Index,PI
Measured: follow-up time point(at least 6 months after restoration)
Bleeding on Probing, BOP
Measured: follow-up time point(at least 6 months after restoration)
Peri-implant Probing Depth, PPD
Measured: follow-up time point(at least 6 months after restoration)
Marginal Bone Loss, MBL
Measured: follow-up time point(at least 6 months after restoration)
Patient Satisfaction
Visual Analog Scale
Measured: follow-up time point(at least 6 months after restoration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start23 May 2024
- Primary completionAug 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge In MandibleStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088172
- Sponsor's protocol ID
- 2024-064
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Keratinized Mucosa Augmentation Around Dental Implant With Free Gingival Graft in Different Surgical Timing at Mandibular Posterior Sites
- ClinicalTrials.gov ID
- NCT07088172
- Acronym / sponsor ID
- 2024-064
- Conditions
- Edentulous Alveolar Ridge In Mandible
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Jul 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.
This study aims to compare clinical outcomes and tissue stability at implant sites in the mandibular posterior region with insufficient buccal keratinized gingiva. It will assess the use of free gingival grafts either before or during the second stage of implant surgery.
Detailed description
To compare the clinical outcomes and the differences in hard and soft tissue stability at implant sites with insufficient buccal keratinized gingiva in the mandibular posterior region, where free gingival grafts are applied either before implant surgery or concurrently during the second stage of implant surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free gingival grafting during the second stage of implant surgery | Experimental | Procedure: free gingival grafts during the second stage of implant surgeryFree gingival graft surgery performed simultaneously with the second stage of the implant surgery, followed by the restoration 6-8 weeks later. |
| free gingival grafts prior to the implantation | Other | Procedure: free gingival grafts prior to the implantaionFree gingival graft surgery is performed 6-8 weeks before implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years, gender unrestricted;
- partially edentulous in the mandible posterior area, planned for implant-supported fixed restoration;
- Buccal keratinized mucosa width at the implant site is less than 2mm, with the transplantation area not exceeding 2 teeth;
- No soft tissue augmentation performed at the site prior to surgery;
- Overall health is good, with no systemic diseases that may affect bone metabolism or wound healing;
Key exclusion criteria (5 listed)
- Uncontrolled metabolic diseases;
- Severe periodontal disease, with unstable periodontal condition;
- Smoking > 10 cigarettes per day;
- Unwilling to participate in the follow-up of this study;
- Other conditions that do not meet the requirements for implant 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 |
|---|---|---|
| free gingival grafts during the second stage of implant surgeryFree gingival graft surgery performed simultaneously with implant stage II, followed by upper restoration 6-8 weeks later. | Procedure or surgery | free gingival grafting during the second stage of implant surgery |
| free gingival grafts prior to the implantaionFree gingival graft surgery performed 6-8 weeks before implant placement | Procedure or surgery | free gingival grafts prior to the implantation |
Primary outcome
Width of Keratinized Mucosa, KMW
Time frame: Preoperative\Immediate postoperative\2 months postoperative\6 months postoperative
7 secondary outcomes
Thickness of Keratinized Mucosa, KMT
Time frame: Preoperative\ Immediate postoperative\2 months postoperative\6 months postoperative
Postoperative Discomfort
Time frame: follow-up time point(at least 6 months after restoration)
Plaque Index,PI
Time frame: follow-up time point(at least 6 months after restoration)
Bleeding on Probing, BOP
Time frame: follow-up time point(at least 6 months after restoration)
Peri-implant Probing Depth, PPD
Time frame: follow-up time point(at least 6 months after restoration)
Marginal Bone Loss, MBL
Time frame: follow-up time point(at least 6 months after restoration)
Patient Satisfaction
Time frame: follow-up time point(at least 6 months after restoration)
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 28 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free gingival grafts during the second stage of implant surgery and free gingival grafts prior to the implantaion in people with Edentulous Alveolar Ridge In Mandible, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 28 Jul 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 China. 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 Misi Si (+86 18605712858, misi_si@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of Keratinized Mucosa, KMW (time frame: Preoperative\Immediate postoperative\2 months postoperative\6 months postoperative). 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 28 Jul 2025.