Inadequately Attached GingivaNCT05273476
Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft
A study testing apically repositioned flap+ xenogeneic collagen matrix +free gingival graft in people with Inadequately Attached Gingiva, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inadequately Attached Gingiva
- What is being tested?
- apically repositioned flap+ xenogeneic collagen matrix +free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >=18 years and periodontally and systemically healthy;
- Presence of at least one site with <=2 mm of keratinized tissue; associated with a shallow vestibule in the edentulous region after implant surgery (no more than three consecutive implants);
- Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
- Full mouth probing depths <=5mm;
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <=15%;
- Be able to comply with all procedures related to the study.
Who cannot join
- Smoking;
- Pregnant or lactating women;
- Untreated periodontal disease;
- Presence of systemic disorders (diabetes, heart disease, tumor or any other condition that could contraindicate periodontal surgery);
- Use of medications (immunosuppressants, phenytoin, or anything else that might affect mucosal healing and repair);
- Under radiotherapy;
- Allergy to the collagen;
- Previous mucogingival surgery in the area.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: Augmentation of Keratinized Tissue Around Dental Implant With Combined Application of a Xenogeneic Collagen Matrix and the Free Gingival Graft : a Single Arm Clinical Trial
The purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft.
Read the detailed description
The purpose of this study is to compare the clinical effects of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft. This study designed a single arm clinical trial. The included patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix and the free gingival graft. The width of keratinized mucosa, thickness of keratinized mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months postoperatively.
- Conditions
- Inadequately Attached Gingiva
- Being tested
- apically repositioned flap+ xenogeneic collagen matrix +free gingival graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apically repositioned flap+ xenogeneic collagen matrix +free gingival graftProcedure or surgery
Harvest a strip free gingival graft from the palate, then place it above apically repositioned flap and fix xenogeneic collagen matrix to the recipient bed
| Study group | Role | What they receive |
|---|---|---|
| strip | Experimental | apically repositioned flap+ xenogeneic collagen matrix +free gingival graft Receives: Procedure: apically repositioned flap+ xenogeneic collagen matrix +free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline keratinized mucosa width at 2 and 6 months
measured from the mucogingival junction to the mucosa margin or the zenith of alveolar ridge at the mid-buccal aspect of each implant using a periodontal probe (UNC15)
Measured: baseline, at 2,6 months
Secondary outcomes (10)
change from baseline keratinized mucosa thickness at 2 and 6 months
measured at the middle point of an apical-coronal direction at the mid-buccal aspect using an endodontic file with a rubber stop
Measured: baseline, at 2,6 months
change from baseline Gingival index at 2 and 6 months
assessed at four gingival sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, and palatal/lingual) . Indicated by numbers, 0: normal gingiva; 1: slightly edematous gingiva that does not bleed on probing; 2: edematous gingiva that bleeds on probing; 3: gingiva that has a tendency to bleed spontaneously or ulcerate.
Measured: baseline, at 2,6 months
change from baseline probing depth at 2 and 6 months
measured at six sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, mesio-palatal/lingual, mid-palatal/lingual, and disto-palatal/lingual) using a periodontal probe (UNC15)
Measured: baseline, at 2,6 months
Post-operative pain
evaluated using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Measured: at 1 week after surgery
change from 2 months patient satisfaction at 6 months
using a visual analog scale (VAS) ranging from 0 to 10 (0 = extremely dissatisfied and 10 = extremely satisfied)
Measured: at 2 and 6 months post operation
dosage of postoperative analgesic drugs
dosage of postoperative analgesic drugs that patients take after surgery
Measured: at 1 week after surgery
operation time
measured from the start of the first incision to the end of the last suture
Measured: during the surgery
esthetic score
assessed by judging on the colour, contour, and texture of the surgical sites
Measured: at 6 months post operation
change from baseline depth of recession at 2 and 6 months
The distance from the implant margin to the gingival margin was measured with a periodontal probe
Measured: baseline, at 2,6 months
change from baseline width of recession at 2 and 6 months
The proximal and distal level of soft tissue retraction at the top of implant was measured by periodontal probe
Measured: baseline, at 2,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start15 Mar 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequately Attached GingivaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peihui Ding, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Peihui Ding, Doctor, Principal investigator, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273476
- Sponsor's protocol ID
- DHZhejiangU-2022（023）
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2022
- Last updated
- 15 Sep 2023
- Results posted
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Keratinized Tissue Around Dental Implant With Combined Application of a Xenogeneic Collagen Matrix and the Free Gingival Graft : a Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05273476
- Acronym / sponsor ID
- DHZhejiangU-2022（023）
- Conditions
- Inadequately Attached Gingiva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 10 Mar 2022 (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 purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft.
Detailed description
The purpose of this study is to compare the clinical effects of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft. This study designed a single arm clinical trial. The included patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix and the free gingival graft. The width of keratinized mucosa, thickness of keratinized mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| strip | Experimental | Procedure: apically repositioned flap+ xenogeneic collagen matrix +free gingival graftapically repositioned flap+ xenogeneic collagen matrix +free gingival graft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged >=18 years and periodontally and systemically healthy;
- Presence of at least one site with <=2 mm of keratinized tissue; associated with a shallow vestibule in the edentulous region after implant surgery (no more than three consecutive implants);
- Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
- Full mouth probing depths <=5mm;
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <=15%;
Key exclusion criteria (8 listed)
- Smoking;
- Pregnant or lactating women;
- Untreated periodontal disease;
- Presence of systemic disorders (diabetes, heart disease, tumor or any other condition that could contraindicate periodontal surgery);
- Use of medications (immunosuppressants, phenytoin, or anything else that might affect mucosal healing and repair);
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 |
|---|---|---|
| apically repositioned flap+ xenogeneic collagen matrix +free gingival graftHarvest a strip free gingival graft from the palate, then place it above apically repositioned flap and fix xenogeneic collagen matrix to the recipient bed | Procedure or surgery | strip |
Primary outcome
change from baseline keratinized mucosa width at 2 and 6 months
Time frame: baseline, at 2,6 months
measured from the mucogingival junction to the mucosa margin or the zenith of alveolar ridge at the mid-buccal aspect of each implant using a periodontal probe (UNC15)
10 secondary outcomes
change from baseline keratinized mucosa thickness at 2 and 6 months
Time frame: baseline, at 2,6 months
change from baseline Gingival index at 2 and 6 months
Time frame: baseline, at 2,6 months
change from baseline probing depth at 2 and 6 months
Time frame: baseline, at 2,6 months
Post-operative pain
Time frame: at 1 week after surgery
change from 2 months patient satisfaction at 6 months
Time frame: at 2 and 6 months post operation
dosage of postoperative analgesic drugs
Time frame: at 1 week after surgery
operation time
Time frame: during the surgery
esthetic score
Time frame: at 6 months post operation
change from baseline depth of recession at 2 and 6 months
Time frame: baseline, at 2,6 months
change from baseline width of recession at 2 and 6 months
Time frame: baseline, at 2,6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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.
Peihui Ding, Doctor principal investigator
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apically repositioned flap+ xenogeneic collagen matrix +free gingival graft in people with Inadequately Attached Gingiva, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 15 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline keratinized mucosa width at 2 and 6 months (time frame: baseline, at 2,6 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 15 Sep 2023.