Keratinized MucosaNCT04410614
Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites
A study testing Free epithelial (gingival) graft in people with Keratinized Mucosa, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
For the management of peridontal and peri-implant conditions, free epithelial grafts have been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing confort during brushing and reducing the level of inflammation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratinized Mucosa
- What is being tested?
- Free epithelial (gingival) graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2020to 1 Jul 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in need of keratinized mucosa to improve the periodontal and peri-implant condition
- With no uncontrolled disease
- Non-smokers
Who cannot join
- Patients with uncontrolled diseases and conditions
- Smokers
- Patients with sufficient keratinized mucosa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites: A Prospective Clinical Study
For the management of peridontal and peri-implant conditions, free epithelial grafts have been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing confort during brushing and reducing the level of inflammation. Nevertheless, these are subjected to dimensional changes that may jeopardise the final outcome of providing sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim at shedding light on the dimensional changes and the variables affecting these changes.
- Conditions
- Keratinized Mucosa
- Being tested
- Free epithelial (gingival) graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free epithelial (gingival) graftProcedure or surgery
1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa
| Study group | Role | What they receive |
|---|---|---|
| Free epithelial graft | Experimental | Free epithelial graft at implant and teeth sites to increase the band of keratinized mucosa Receives: Procedure: Free epithelial (gingival) graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in keratinized mucosa
Area of keratinized mucosa gain
Measured: 3 weeks, 3 months, 6 months follow-up
Secondary outcomes (3)
Factor 1 affecting the dimensional changes
Avascular area exposed to the graft (implant/tooth surface)
Measured: 3 weeks, 3 months, 6 months
Factor 2 affecting the dimensional changes
Thickness in mm of the graft
Measured: 3 weeks, 3 months, 6 months
Factor 3 affecting the dimensional changes
Thickness in mm of the recipient connective tissue
Measured: 3 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start25 May 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Keratinized MucosaStudies 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
- Model description
- Teeth and implants receiving free epithelial grafts harvested from the palate
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410614
- Sponsor's protocol ID
- 21052020
- Status last verified
- Sep 2021
- First submitted
- 27 May 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.
PubMed 30461016Monje A, Blasi G, Amerio E, Sanz-Martin I, Nart J. Dimensional changes in free epithelialized gingival/mucosal grafts at tooth and implant sites: A prospective cohort study. J Periodontol. 2022 Jul;93(7):1014-1023. doi: 10.1002/JPER.21-0521. Epub 2022 Jan 25.
PubMed 34970744
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04410614
- Acronym / sponsor ID
- 21052020
- Conditions
- Keratinized Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 1 Jun 2020 (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.
For the management of peridontal and peri-implant conditions, free epithelial grafts have been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing confort during brushing and reducing the level of inflammation. Nevertheless, these are subjected to dimensional changes that may jeopardise the final outcome of providing sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim at shedding light on the dimensional changes and the variables affecting these changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Teeth and implants receiving free epithelial grafts harvested from the palate
| Arm | Type | Receives |
|---|---|---|
| Free epithelial graft | Experimental | Procedure: Free epithelial (gingival) graftFree epithelial graft at implant and teeth sites to increase the band of keratinized mucosa |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in need of keratinized mucosa to improve the periodontal and peri-implant condition
- With no uncontrolled disease
- Non-smokers
Key exclusion criteria (3 listed)
- Patients with uncontrolled diseases and conditions
- Smokers
- Patients with sufficient keratinized mucosa
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 epithelial (gingival) graft1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa | Procedure or surgery | Free epithelial graft |
Primary outcome
Change in keratinized mucosa
Time frame: 3 weeks, 3 months, 6 months follow-up
Area of keratinized mucosa gain
3 secondary outcomes
Factor 1 affecting the dimensional changes
Time frame: 3 weeks, 3 months, 6 months
Factor 2 affecting the dimensional changes
Time frame: 3 weeks, 3 months, 6 months
Factor 3 affecting the dimensional changes
Time frame: 3 weeks, 3 months, 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 10 Sep 2021.
- Background: PubMed 30461016Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.
- Derived from this study: PubMed 34970744Monje A, Blasi G, Amerio E, Sanz-Martin I, Nart J. Dimensional changes in free epithelialized gingival/mucosal grafts at tooth and implant sites: A prospective cohort study. J Periodontol. 2022 Jul;93(7):1014-1023. doi: 10.1002/JPER.21-0521. Epub 2022 Jan 25.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 epithelial (gingival) graft in people with Keratinized Mucosa, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
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 3 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 10 Sep 2021. 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 Spain. 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 in keratinized mucosa (time frame: 3 weeks, 3 months, 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410614, which also lists 2 linked publications.
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 10 Sep 2021.