Gingival RecessionNCT05684068
Dimensional Changes: Randomized Clinical Trial
A study testing Gum Graft Placed on Denuded Bone and Gum Graft Placed on Split Thickness Periosteal Bed Preparation in people with Gingival Recession, run by University of Iowa at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gum Graft Placed on Denuded Bone and Gum Graft Placed on Split Thickness Periosteal Bed Preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2028to Mar 2031
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18-95 years of age
- Inactive periodontal disease
- Lack of, or an insufficient (less than 2 millimeters) band of keratinized tissue width on the buccal site (closest to the cheek)
- Shallow vestibule depth (the space between the soft tissue (lips and cheeks), and the teeth and gums)
- Thin gingival phenotype (less than 1.5mm of gum tissue depth).
- Aberrant frenum attachment in need of free-epithelized gingival grafts.
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- At least one RT1, 2, or 3 (Cairo's classification) gingival recession defect on the mandibular anterior sextant (Teeth #22-27).
- Non-smokers or past smokers (those who have stopped at minimum 6 months ago).
- Patient willing and able to follow instruction related to the study procedures.
Who cannot join
- Previous soft tissue augmentation procedures at the area of interest.
- Current smokers (Light smokers meaning less than 10 cigarettes/day, heavy smokers meaning more than 10 cigarettes/day, or social smokers)
- Uncontrolled systemic disease (uncontrolled diabetes defined by blood sugar HbA1c greater than 7%)
- Any active local or systemic infections
- Any diseases or medications that may compromise normal wound healing
- Currently receiving chemotherapy or radiotherapy or a history of radiotherapy in head and neck area.
Show all 10Show fewer
- Severe hematologic (blood) disorders
- Pregnancy or nursing mother
- Patients undergoing orthodontic therapy
- Patients taking antibiotics in the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, 52242
Carlos Garaicoa Pazmino, DDS, MS, (319) 467-4315, carlos-garaicoapazmino@uiowa.edu
About this study
Official title: Dimensional Changes of Autogenous Free Epithelialized Gingival Grafts on Different Bed Preparations Among Dental Patients With Thin Tissue Phenotypes: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining.
The main question this study aims to answer is:
Read more
- Does the placement of free-epithelized gingival grafts (gum grafts) on full thickness bed preparation (having all of the tissue removed from the bone) lead to similar clinical, digital, and patient-related outcomes and measurements over a period of 12 months versus split thickness bed preparation (where a small layer of tissue is left over the bone) in patients with thin gum tissue phenotypes (gum tissue is generally less than 1.5 millimeters) who are in need of soft tissue augmentation procedures?
Participants will be asked to attend 8 visits, which include: (i) screening visit, (ii) prophylaxis visit, (iii) random assignment to Group A or Group B along with surgery and digital data collection, (iv) 2-week post-operative visit, (v) 6-week post-operative visit, (vi) 3-month follow-up visit, (vii) 6-month follow-up visit, (viii) 12-month follow-up visit. Also, Group A will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Researchers will compare Group A and Group B to see if there is a difference in clinical, digital, and patient-related outcomes and measurements over a period of 12 months.
- Conditions
- Gingival Recession
- Being tested
- Gum Graft Placed on Denuded Bone, Gum Graft Placed on Split Thickness Periosteal Bed Preparation
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum Graft Placed on Denuded BoneProcedure or surgery
The provider will administer local anesthesia into the subject's gum in order to numb both the subject's donor and recipient areas for gum grafts. Next, the provider will use a surgical blade to dissect the gum graft from the subject's donor site. At the subject's recipient gum recession defect site, the provider will remove all of the subject's tissue, so that the bone is fully exposed before placing a gum graft from the donor site. Afterward, the provider will place sutures in the subject's recipient site in order to promote healing/re-growth.
Gum Graft Placed on Split Thickness Periosteal Bed PreparationProcedure or surgery
The provider will administer local anesthesia into the subject's gum in order to numb both the subject's donor and recipient areas for gum grafts. Next, the provider will use a surgical blade to dissect the gum graft from the subject's donor site. At the subject's recipient gum recession defect site, the provider will dissect some of the tissue at the subject's recipient site but still keep a small layer of tissue at the subject's recipient site before placing a gum graft from the donor site. Afterward, the provider will place sutures in the subject's recipient site in order to promote healing/re-growth.
| Study group | Role | What they receive |
|---|---|---|
| Gum Graft Placed on Denuded Bone | Experimental | Subjects in this arm will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Receives: Procedure: Gum Graft Placed on Denuded Bone |
| Gum Graft Placed on Split Thickness Periosteal Bed Preparation | Active comparator | Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Receives: Procedure: Gum Graft Placed on Split Thickness Periosteal Bed Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Gingival Thickness as assessed by measurement.
Tissue changes will be assessed in millimeters and percentage.
Measured: Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study startAug 2028 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Garaicoa Pazmino, University of Iowa
- Investigators
- Carlos Garaicoa, DDS, MS, Principal investigator, University of Iowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684068
- Sponsor's protocol ID
- 202207368
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Changes of Autogenous Free Epithelialized Gingival Grafts on Different Bed Preparations Among Dental Patients With Thin Tissue Phenotypes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05684068
- Acronym / sponsor ID
- 202207368
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Aug 2028 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 13 Jan 2023 (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 goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining.
The main question this study aims to answer is:
- Does the placement of free-epithelized gingival grafts (gum grafts) on full thickness bed preparation (having all of the tissue removed from the bone) lead to similar clinical, digital, and patient-related outcomes and measurements over a period of 12 months versus split thickness bed preparation (where a small layer of tissue is left over the bone) in patients with thin gum tissue phenotypes (gum tissue is generally less than 1.5 millimeters) who are in need of soft tissue augmentation procedures?
Participants will be asked to attend 8 visits, which include: (i) screening visit, (ii) prophylaxis visit, (iii) random assignment to Group A or Group B along with surgery and digital data collection, (iv) 2-week post-operative visit, (v) 6-week post-operative visit, (vi) 3-month follow-up visit, (vii) 6-month follow-up visit, (viii) 12-month follow-up visit. Also, Group A will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Researchers will compare Group A and Group B to see if there is a difference in clinical, digital, and patient-related outcomes and measurements over a period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gum Graft Placed on Denuded Bone | Experimental | Procedure: Gum Graft Placed on Denuded BoneSubjects in this arm will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). |
| Gum Graft Placed on Split Thickness Periosteal Bed Preparation | Active comparator | Procedure: Gum Graft Placed on Split Thickness Periosteal Bed PreparationGroup B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients 18-95 years of age
- Inactive periodontal disease
- Lack of, or an insufficient (less than 2 millimeters) band of keratinized tissue width on the buccal site (closest to the cheek)
- Shallow vestibule depth (the space between the soft tissue (lips and cheeks), and the teeth and gums)
- Thin gingival phenotype (less than 1.5mm of gum tissue depth).
Key exclusion criteria (10 listed)
- Previous soft tissue augmentation procedures at the area of interest.
- Current smokers (Light smokers meaning less than 10 cigarettes/day, heavy smokers meaning more than 10 cigarettes/day, or social smokers)
- Uncontrolled systemic disease (uncontrolled diabetes defined by blood sugar HbA1c greater than 7%)
- Any active local or systemic infections
- Any diseases or medications that may compromise normal wound healing
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 |
|---|---|---|
| Gum Graft Placed on Denuded BoneThe provider will administer local anesthesia into the subject's gum in order to numb both the subject's donor and recipient areas for gum grafts. Next, the provider will use a surgical blade to dissect the gum graft from the subject's donor site. At the subject's recipient gum recession defect site, the provider will remove all of the subject's tissue, so that the bone is fully exposed before placing a gum graft from the donor site. Afterward, the provider will place sutures in the subject's recipient site in order to promote healing/re-growth. | Procedure or surgery | Gum Graft Placed on Denuded Bone |
| Gum Graft Placed on Split Thickness Periosteal Bed PreparationThe provider will administer local anesthesia into the subject's gum in order to numb both the subject's donor and recipient areas for gum grafts. Next, the provider will use a surgical blade to dissect the gum graft from the subject's donor site. At the subject's recipient gum recession defect site, the provider will dissect some of the tissue at the subject's recipient site but still keep a small layer of tissue at the subject's recipient site before placing a gum graft from the donor site. Afterward, the provider will place sutures in the subject's recipient site in order to promote healing/re-growth. | Procedure or surgery | Gum Graft Placed on Split Thickness Periosteal Bed Preparation |
Primary outcome
Change from Baseline in Gingival Thickness as assessed by measurement.
Time frame: Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)
Tissue changes will be assessed in millimeters and percentage.
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 9 Sep 2026.
- 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.
Carlos Garaicoa, DDS, MS principal investigator
University of Iowa College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum Graft Placed on Denuded Bone and Gum Graft Placed on Split Thickness Periosteal Bed Preparation in people with Gingival Recession, run by University of Iowa 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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?
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?
Contact Carlos Garaicoa Pazmino, DDS, MS ((319) 467-4315, carlos-garaicoapazmino@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Gingival Thickness as assessed by measurement. (time frame: Multiple time points (i.e., Baseline, 3 months, 6 months, 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 9 Sep 2026.