Dental ImplantsNCT03338686
To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
A study testing Free Gingival Graft (FGG) and Connective Tissue Graft followed by Laser Gingivoplasty in people with Dental Implants and Alveolar Mucosa, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Alveolar Mucosa
- What is being tested?
- Free Gingival Graft (FGG) and Connective Tissue Graft followed by Laser Gingivoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2016to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School, able to read and understand informed consent document
- One or more adjacent dental implants having <2mm in width of keratinized mucosa or attached mucosa <1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
- No crestal bone loss or minimal bone resorption not extending apical to first implant thread
- Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)
- Implants requiring soft tissue grafting after placement (>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration
Who cannot join
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
- Presence of soft tissue recession exposing threads at implant site
- Presence of bony dehiscence at implant site (s)_ at time of surgery
- Previous soft tissue grafting at the implant site (s)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007
About this study
Official title: A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.
To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
Read the detailed description
Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions.
Specific aims for this project include the evaluation of:
- KM width at 6 and 12 months following grafting with FGG and CTG
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month
- Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group
- Conditions
- Dental Implants, Alveolar Mucosa
- Being tested
- Free Gingival Graft (FGG), Connective Tissue Graft followed by Laser Gingivoplasty
- Keywords
- Keratinized tissue, Keratinized mucosa, Attached mucosa, Dental implants, Free gingival graft, Connective tissue graft, Patient-centered outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival Graft (FGG)Procedure or surgery
Also called palatal autogenous soft tissue graft
Free Gingival Graft (FGG) was performed on all study sites in this arm.
Connective Tissue Graft followed by Laser GingivoplastyProcedure or surgery
Also called palatal autogenous subepithelial soft tissue graft
Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Free Gingival Graft | Active comparator | Free Gingival Graft (FGG) Receives: Procedure: Free Gingival Graft (FGG) |
| Connective Tissue Graft followed by Laser Gingivoplasty | Experimental | Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Receives: Procedure: Connective Tissue Graft followed by Laser Gingivoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.
Measured: From baseline to 12 months
Secondary outcomes (2)
Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
Measured: From baseline to 12 months
Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start7 Jan 2016
- Primary completion9 Oct 2018
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramzi V. Abou-Arraj, University of Alabama at Birmingham
- Investigators
- Ramzi V Abou-Arraj, DDS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338686
- Sponsor's protocol ID
- STS-15
- Status last verified
- Aug 2021
- First submitted
- 3 Oct 2017
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
- ClinicalTrials.gov ID
- NCT03338686
- Acronym / sponsor ID
- STS-15
- Conditions
- Dental Implants, Alveolar Mucosa
- Keywords
- Keratinized tissue, Keratinized mucosa, Attached mucosa, Dental implants, Free gingival graft, Connective tissue graft, Patient-centered outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.
To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
Detailed description
Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions.
Specific aims for this project include the evaluation of:
- KM width at 6 and 12 months following grafting with FGG and CTG
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month
- Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free Gingival Graft | Active comparator | Procedure: Free Gingival Graft (FGG)Free Gingival Graft (FGG) |
| Connective Tissue Graft followed by Laser Gingivoplasty | Experimental | Procedure: Connective Tissue Graft followed by Laser GingivoplastyConnective Tissue Graft (CTG) followed by Laser Gingivoplasty |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School, able to read and understand informed consent document
- One or more adjacent dental implants having <2mm in width of keratinized mucosa or attached mucosa <1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
- No crestal bone loss or minimal bone resorption not extending apical to first implant thread
Key exclusion criteria (8 listed)
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
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 (FGG)Also: palatal autogenous soft tissue graftFree Gingival Graft (FGG) was performed on all study sites in this arm. | Procedure or surgery | Free Gingival Graft |
| Connective Tissue Graft followed by Laser GingivoplastyAlso: palatal autogenous subepithelial soft tissue graftConnective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm. | Procedure or surgery | Connective Tissue Graft followed by Laser Gingivoplasty |
Primary outcome
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
Time frame: From baseline to 12 months
Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.
2 secondary outcomes
Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG
Time frame: From baseline to 12 months
Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG
Time frame: From baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ramzi V Abou-Arraj, DDS, MS principal investigator
University of Alabama at Birmingham
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 (FGG) and Connective Tissue Graft followed by Laser Gingivoplasty in people with Dental Implants and Alveolar Mucosa, run by University of Alabama at Birmingham at 1 site in United States.
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 7 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 22 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts (time frame: From baseline to 12 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 22 Sep 2021.