Keratinized MucosaNCT04861662
Effect of Keratinized Mucosa on Peri-implant Health
A study testing Free gingival graft procedure in people with Keratinized Mucosa and Dental Implant, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratinized Mucosa, Dental Implant, Free Gingival Graft
- What is being tested?
- Free gingival graft procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2018to 30 Jun 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over the age of 18
- Having dental implant treatment and prosthetic restoration
- Not having received bone augmentation treatment at the implant site
- To comply with maintenance controls after dental implant treatment
Who cannot join
- Pregnancy
- Having used systemic antibiotics within 6 weeks prior to the start of the study
- Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus
- Using drugs that cause immunosuppression
- Using a medicine that affects bone metabolism, such as a bisphosphonate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health
The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.
Read the detailed description
The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.
- Conditions
- Keratinized Mucosa, Dental Implant, Free Gingival Graft
- Being tested
- Free gingival graft procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft procedureProcedure or surgery
Free gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them
| Study group | Role | What they receive |
|---|---|---|
| Keratinized Mucosa Sufficient (KMS) | No intervention | Implants exhibiting the width of keratinized mucosa (KM) ≥2 mm at the midbuccal aspect |
| Keratinized Mucosa Deficient (KMD) | No intervention | Implants exhibiting KM<2 mm at the midbuccal aspect |
| Free Gingival Graft (FGG) | Experimental | Implants with KM<2 mm initially and having surgically increased keratinized mucosa with free gingival graft after prothesis delivery Receives: Procedure: Free gingival graft procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Change of marginal bone loss measured from periapical radiographs
Measured: Baseline, 3rd month, 6th month and 1st year
Secondary outcomes (3)
Modified bleeding index
Parameter showing peri-implant mucosa inflammation
Measured: Baseline, 3rd month, 6th month and 1st year
Probing depth
The depth of peri-implant sulcus in millimeters
Measured: Baseline, 3rd month, 6th month and 1st year
Modified plaque index
Parameter showing oral hygiene performance
Measured: Baseline, 3rd month, 6th month and 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start10 Oct 2018
- Primary completion9 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratinized MucosaStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Gürbüz, Kutahya Health Sciences University
- Investigators
- Melike Başaran, Principal investigator, melike_basaran@ksbu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861662
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health
- ClinicalTrials.gov ID
- NCT04861662
- Acronym / sponsor ID
- 01
- Conditions
- Keratinized Mucosa, Dental Implant, Free Gingival Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Apr 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 aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.
Detailed description
The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Keratinized Mucosa Sufficient (KMS) | No intervention | –Implants exhibiting the width of keratinized mucosa (KM) ≥2 mm at the midbuccal aspect |
| Keratinized Mucosa Deficient (KMD) | No intervention | –Implants exhibiting KM<2 mm at the midbuccal aspect |
| Free Gingival Graft (FGG) | Experimental | Procedure: Free gingival graft procedureImplants with KM<2 mm initially and having surgically increased keratinized mucosa with free gingival graft after prothesis delivery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over the age of 18
- Having dental implant treatment and prosthetic restoration
- Not having received bone augmentation treatment at the implant site
- To comply with maintenance controls after dental implant treatment
Key exclusion criteria (5 listed)
- Pregnancy
- Having used systemic antibiotics within 6 weeks prior to the start of the study
- Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus
- Using drugs that cause immunosuppression
- Using a medicine that affects bone metabolism, such as a bisphosphonate
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 graft procedureFree gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them | Procedure or surgery | Free Gingival Graft (FGG) |
Primary outcome
Marginal bone loss
Time frame: Baseline, 3rd month, 6th month and 1st year
Change of marginal bone loss measured from periapical radiographs
3 secondary outcomes
Modified bleeding index
Time frame: Baseline, 3rd month, 6th month and 1st year
Probing depth
Time frame: Baseline, 3rd month, 6th month and 1st year
Modified plaque index
Time frame: Baseline, 3rd month, 6th month and 1st year
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 5 Sep 2021.
Related trials for Keratinized Mucosa
Not yet recruiting
Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
Keratinized Mucosa Deficiency, Peri-implant Soft Tissue
Recruiting
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
Gingival Recession, Lack of Keratinized Attached Peri-implant Mucosa
Active, not recruiting
Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa
Peri-Implantational Loss, Surgical Wound
Recruiting
Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis
Peri-implantitis, Soft Tissue Augmentation at Dental Implants
Active, not recruiting
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Gingival Recession, Lack of Keratinized Gingiva
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.
Melike Başaran principal investigator
melike_basaran@ksbu.edu.tr
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 graft procedure in people with Keratinized Mucosa and Dental Implant, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 5 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 Turkey (Türkiye). 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?
Marginal bone loss (time frame: Baseline, 3rd month, 6th month and 1st year). 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 5 Sep 2021.