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Not yet recruitingNCT05684068Updated Sep 9, 2026

Dimensional Changes: Randomized Clinical Trial

An interventional study of Gum Graft Placed on Denuded Bone and Gum Graft Placed on Split Thickness Periosteal Bed Preparation in Gingival Recession, sponsored by University of Iowa. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by University of Iowa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 45 studies in Gingival Recession with a site in United States — 12 open to participants now, 16 under way, 1 of them phase 3. Gingival Recession · United States.

Planned enrollment
8th of 41
50 · median 24
Started
2028
the only one that year
No phase
32 of 45
11 open now
Primary completion
2030-07
later than 14 of 15 live
Registered
31st of 45
by date

Among the 45 studies in Gingival Recession with a site in United States, this one is the 8th largest by planned enrollment of the 41 interventional ones, is the only one that started in 2028, is one of 32 with no phase, reaches primary completion later than 14 of the 15 other live ones, and was the 31st registered.

By phase

45 studies; the count open now beside each. This study's row is marked.

No phasethis study32 · 11 open
Observational4 · 1 open
Phase 44 · 0 open
Phase 12 · 0 open
Phase 32 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2028.

Size and results

Median enrollment 24 across the 41 interventional studies, 24 across the 4 observational. Of the 25 that completed or were terminated, 7 (28%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 45 studies in Gingival Recession with a site in United States, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Gingival Recession

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04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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.
  • Severe hematologic (blood) disorders
  • Pregnancy or nursing mother
  • Patients undergoing orthodontic therapy
  • Patients taking antibiotics in the past 3 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Gum Graft Placed on Denuded Bone

    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).

    Procedure: Gum Graft Placed on Denuded Bone

  • Active comparator
    Gum Graft Placed on Split Thickness Periosteal Bed Preparation

    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).

    Procedure: Gum Graft Placed on Split Thickness Periosteal Bed Preparation

Interventions

  • ProcedureGum Graft Placed on Denuded Bone

    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.

  • ProcedureGum Graft Placed on Split Thickness Periosteal Bed Preparation

    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.

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Gingival Thickness as assessed by measurement.

    Tissue changes will be assessed in millimeters and percentage.

    Time frame: Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2028; primary completion for Jul 2030, 23 months later.

Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 23 months is above that.

Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2023
First posted
Jan 13, 2023
StartEst.
Aug 2028
Primary completionEst.
Jul 2030
CompletionEst.
Mar 2031
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05684068
Lead sponsor
University of Iowa
Responsible party
Carlos Garaicoa Pazmino (Clinical Assistant Professor, University of Iowa) — Principal investigator
First posted
Jan 13, 2023
Start date
Aug 2028 (estimated)
Primary completion
Jul 2030 (estimated)
Completion
Mar 2031 (estimated)
Last update
Sep 9, 2026

Study contacts

Carlos Garaicoa Pazmino, DDS, MS
Contact
carlos-garaicoapazmino@uiowa.edu
(319) 467-4315
Carlos Garaicoa, DDS, MS
principal investigator · University of Iowa College of Dentistry

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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