Edentulous Alveolar RidgeNCT07124416
The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
An observational study of Edentulous Alveolar Ridge, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study aims to conduct a cross-sectional study to compare the differences in clinical indices, patient-reported outcomes, and levels of inflammatory factors in peri-implant gingival crevicular fluid between sites with adequate (≥ 2 mm) and inadequate (< 2 mm) keratinized mucosa after implant restoration, in order… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Edentulous Alveolar Ridge
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to Dec 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have completed dental implant restoration（single crown or fixed bridge restorations） for at least 6 months and undergo routine follow-up examinations.
Who may be able to join
- Individuals aged 18 to 70 years (inclusive of 18 and 70 years), of any gender;
- Patients who have undergone dental implant restoration是（single crown or fixed bridge restorations） at the Stomatology Hospital, Zhejiang University School of medicine and have had their final restoration for at least 6 months;
- Patients who voluntarily participate and sign the informed consent form after being fully informed, and who cooperate with relevant examinations.
Who cannot join
- Patients who are unwilling to participate in the follow-up of this study for various reasons
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 conduct a cross-sectional study to compare the differences in clinical indices, patient-reported outcomes, and levels of inflammatory factors in peri-implant gingival crevicular fluid between sites with adequate (≥ 2 mm) and inadequate (< 2 mm) keratinized mucosa after implant restoration, in order to explore the impact of the presence of keratinized mucosa on peri-implant soft and hard tissue health.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention: observational case-control study
| Study group | Role | What they receive |
|---|---|---|
| inadequate keratinized mucosa | peri-implant width of keratinized mucosa less than 2 mm | |
| adequate keratinized mucosa | peri-implant width of keratinized mucosa ≥ 2 mm Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of Keratinized Mucosa, KMW
Measured: on the day of enrollment
Plaque Index(PI)
Measured: on the day of enrollment
Bleeding on Probing(BOP)
Measured: on the day of enrollment
Peri-implant Probing Depth(PPD)
Measured: on the day of enrollment
Marginal Bone Loss(MBL)
Measured: The X-ray examination will be completed on the day of enrollment
Patient Satisfaction
visual analogue scale [VAS] 0-10,e.g., not at all satisfied to perfectly satisfied
Measured: on the day of enrollment
Immunological parameters in peri-implant crevicular fluids(PICF)
PICF samples were collected from buccal aspects of implants after removing all supragingival plaque. The levels of IL-1β and PGE2 in PICF were measured using a sandwich ELISA kit.
Measured: The PICF will be collected on the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start10 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 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
- NCT07124416
- Sponsor's protocol ID
- 2025-104
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2025
- Last updated
- 15 Aug 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
- ClinicalTrials.gov ID
- NCT07124416
- Acronym / sponsor ID
- 2025-104
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 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 conduct a cross-sectional study to compare the differences in clinical indices, patient-reported outcomes, and levels of inflammatory factors in peri-implant gingival crevicular fluid between sites with adequate (≥ 2 mm) and inadequate (< 2 mm) keratinized mucosa after implant restoration, in order to explore the impact of the presence of keratinized mucosa on peri-implant soft and hard tissue health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inadequate keratinized mucosa | – | –peri-implant width of keratinized mucosa less than 2 mm |
| adequate keratinized mucosa | – | Other: No interventionperi-implant width of keratinized mucosa ≥ 2 mm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have completed dental implant restoration（single crown or fixed bridge restorations） for at least 6 months and undergo routine follow-up examinations.
Key inclusion criteria (3 listed)
- Individuals aged 18 to 70 years (inclusive of 18 and 70 years), of any gender;
- Patients who have undergone dental implant restoration是（single crown or fixed bridge restorations） at the Stomatology Hospital, Zhejiang University School of medicine and have had their final restoration for at least 6 months;
- Patients who voluntarily participate and sign the informed consent form after being fully informed, and who cooperate with relevant examinations.
Key exclusion criteria (1 listed)
- Patients who are unwilling to participate in the follow-up of this study for various reasons
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 |
|---|---|---|
| No interventionNo intervention: observational case-control study | Other | adequate keratinized mucosa |
Primary outcome
Width of Keratinized Mucosa, KMW
Time frame: on the day of enrollment
Plaque Index(PI)
Time frame: on the day of enrollment
Bleeding on Probing(BOP)
Time frame: on the day of enrollment
Peri-implant Probing Depth(PPD)
Time frame: on the day of enrollment
Marginal Bone Loss(MBL)
Time frame: The X-ray examination will be completed on the day of enrollment
Patient Satisfaction
Time frame: on the day of enrollment
visual analogue scale [VAS] 0-10,e.g., not at all satisfied to perfectly satisfied
Immunological parameters in peri-implant crevicular fluids(PICF)
Time frame: The PICF will be collected on the day of enrollment
PICF samples were collected from buccal aspects of implants after removing all supragingival plaque. The levels of IL-1β and PGE2 in PICF were measured using a sandwich ELISA kit.
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 15 Aug 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?
An observational study of Edentulous Alveolar Ridge, 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 3 inclusion and 1 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 15 Aug 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: on the day of enrollment). The study lists 7 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 15 Aug 2025.