Dimensional Changes: Randomized Clinical Trial

NCT ID: NCT05684068

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-08-31
• Study Completion Date: 2031-03-31

Brief 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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Gum Graft Placed on Denuded Bone

Intervention Type: PROCEDURE

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 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).

Group Type: ACTIVE_COMPARATOR

Gum Graft Placed on Split Thickness Periosteal Bed Preparation

Intervention Type: PROCEDURE

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.

Interventions

Gum 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.

Intervention Type: PROCEDURE

Gum 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.
• Severe hematologic (blood) disorders
• Pregnancy or nursing mother
• Patients undergoing orthodontic therapy
• Patients taking antibiotics in the past 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Carlos Garaicoa Pazmino

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Garaicoa, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa College of Dentistry

Locations

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, United States

Countries

United States

Central Contacts

Carlos Garaicoa Pazmino, DDS, MS

Role: CONTACT

carlos-garaicoapazmino@uiowa.edu

(319) 467-4315

Facility Contacts

Carlos Garaicoa Pazmino, DDS, MS

Role: primary

carlos-garaicoapazmino@uiowa.edu

(319) 467-4315

Other Identifiers

202207368

Identifier Type: -

Identifier Source: org_study_id