Variation of Keratinized Mucosa After Implant SurgeryNCT05073952
Keratized Mucosa in CG Implant Placement: CTG vs Flapless
A study testing Connective tissue graft and Flapless in people with Variation of Keratinized Mucosa After Implant Surgery, run by University of Milan at 1 site in Italy.
Trial summary
The present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Variation of Keratinized Mucosa After Implant Surgery
- What is being tested?
- Connective tissue graft and Flapless
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2021to 1 Jun 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Patients with partial edentulism in the posterior region (4-7) upper or lower for at least 3 months
- Patient whose tomographic examination shows adequate bone volumes for computer guided placement of a standard diameter implant (> 3.5 mm) without the need for bone regeneration procedures
- Patients who have accepted informed consent and participation in the study
- Patients who do not have exclusion criteria
- Eclusion Criteria
Show all 30Show fewer
- Patients who refuse to co-operate
- Systemic conditions of exclusion:
- Medical conditions requiring prolonged use of steroids
- Severe hemophilia
- In therapy with intravenous bisphosphonates
- History of white blood cell dysfunction or deficiency
- History of head and neck radiotherapy or chemotherapy
- History of kidney failure
- Pregnant or breastfeeding patient
- History of uncontrolled endocrine disorders
- Physical handicaps that hinder proper oral hygiene
- Use of experimental devices or drugs within 30 days prior to implant placement surgery
- Alcoholism or drug abuse
- Smokers of> 10 cigarettes per day or the equivalent cigar or> 10 tobacco-based chewings per day
- Conditions or circumstances that prevent the completion of participation in the study or interfere with the analysis of the study results
- Local exclusion conditions:
- Local inflammation, including untreated periodontitis
- Patients with erosive lichen planus
- History of local radiation therapy
- Presence of bone lesions
- Unhealed extraction sites
- History of bone reconstruction and bone grafting techniques in the sites where the implants are to be inserted
- Bruxism
- Bleeding index> 30% and number of pockets> 5mm greater than 10
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Odontoiatrica Giorgio Vogel
Milan, MI, 20142
Stefano Storelli, PHD, 0250319003, stefano.storelli@unimi.it
Eugenio Romeo, Prof., 0250319003, eugenio.romeo@unimi.it
About this study
Official title: Width of Keratinazed Mucosa in Immediately Loaded Posterior Implant Restorations Treated With Different Surgical Approaches: Randomized Clinical Study.
The present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft.
- Being tested
- Connective tissue graft, Flapless
- Keywords
- dental implant, Keratinized mucosa, Connective tissue graft, flapless implant placement, Computer guided implantology, Immediate loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
Implants will be placed with a flap and a connective tissue graft.
FlaplessProcedure or surgery
Implants will be placed with a flapless approach
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft | Active comparator | patient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement. Receives: Procedure: Connective tissue graft |
| Flapess | Active comparator | patient in this group will be treated with a flapless approach at the moment of implant placement. Receives: Procedure: Flapless |
What is being measured
The primary outcome is the main question the study is designed to answer.
Widht of Keratinized mucosa
variation of keratized mucosa from t0
Measured: 2-4-8-12-24 weeks - 1-2-3-4-5 years
Secondary outcomes (3)
implant survival
Implant in function
Measured: 1-2-3-4-5 years
marginal bone loss
variation of marginal bone loss over time
Measured: 1-2-3-4-5 years
Vas Scale
Prom: patient VAS scale for post-operative pain, from 0 to 10, where 10 is higher and 0 is minimum.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start18 Oct 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variation of Keratinized Mucosa After Implant SurgeryStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups will be compared with different treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Storelli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073952
- Sponsor's protocol ID
- KM001
- Status last verified
- Dec 2021
- First submitted
- 17 Sep 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Width of Keratinazed Mucosa in Immediately Loaded Posterior Implant Restorations Treated With Different Surgical Approaches: Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT05073952
- Acronym / sponsor ID
- KM001
- Keywords
- dental implant, Keratinized mucosa, Connective tissue graft, flapless implant placement, Computer guided implantology, Immediate loading
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Oct 2021 (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 present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups will be compared with different treatment
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft | Active comparator | Procedure: Connective tissue graftpatient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement. |
| Flapess | Active comparator | Procedure: Flaplesspatient in this group will be treated with a flapless approach at the moment of implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Age 18+
- Patients with partial edentulism in the posterior region (4-7) upper or lower for at least 3 months
- Patient whose tomographic examination shows adequate bone volumes for computer guided placement of a standard diameter implant (> 3.5 mm) without the need for bone regeneration procedures
- Patients who have accepted informed consent and participation in the study
- Patients who do not have exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Connective tissue graftImplants will be placed with a flap and a connective tissue graft. | Procedure or surgery | Connective tissue graft |
| FlaplessImplants will be placed with a flapless approach | Procedure or surgery | Flapess |
Primary outcome
Widht of Keratinized mucosa
Time frame: 2-4-8-12-24 weeks - 1-2-3-4-5 years
variation of keratized mucosa from t0
3 secondary outcomes
implant survival
Time frame: 1-2-3-4-5 years
marginal bone loss
Time frame: 1-2-3-4-5 years
Vas Scale
Time frame: 2 weeks
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 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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 Connective tissue graft and Flapless in people with Variation of Keratinized Mucosa After Implant Surgery, run by University of Milan at 1 site in Italy.
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 30 inclusion and 0 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 3 Dec 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Widht of Keratinized mucosa (time frame: 2-4-8-12-24 weeks - 1-2-3-4-5 years). 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 3 Dec 2021.