Status:
ACTIVE_NOT_RECRUITING
Free Gingival Grafts (FGGs) in Mandibular Posterior Sites
Lead Sponsor:
Ohio State University
Conditions:
Lack of Keratinized Tissue
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief Summary
In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed pre...
Detailed Description
While the presence of a sufficient size of keratinized oral mucosa is favorable, the surgical procedure to increase the size is technically difficult. In the traditional way, preparation of the gum be...
Eligibility Criteria
Inclusion
- A) Target population: Patients whether edentulous or dentate or treated with root-form dental implants, who need FGG on the buccal aspect of the mandibular posterior area.
- Inclusion criteria \<Demographic\> Race: Any Non-smokers: No use of any tobacco or nicotine-replacement products for the least 5 years
- \<Medical history\>
- Physically and mentally healthy with no contraindication for periodontal surgery
- American Society of Anesthesiologists: ASA-1 or ASA-2
- Clinical (Oral) conditions: Periodontally healthy patients with no contraindication for free gingival graft procedure (donor and recipient sites)
- \<Other\>
- Patients who need free gingival graft in the mandibular posterior area.
- Patients who are able and willing to provide informed consent
- Patients who are able to receive surgery on Tuesday.
- Exclusion criteria \<Medical history\>
- Smokers or users of nicotine replacement products
- Patients with any history of soft tissue surgery (grafting) in the area to be treated
- Patients with contraindication for periodontal soft tissue surgery, including an anatomical location of mental nerve that may restrict preparation of 10x10mm recipient bed
- Patients with contraindication, e.g., allergy, for any of the medications used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen)
- Patients with inadequate donor site anatomy.
- Patients with uncontrolled diabetes (glycemic level \> 110mg/l and HbA1c \> 6%)
- Patients with drug or alcohol abuse
- Pregnant or lactating women
- Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
- Other systemic conditions or medications affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases, phenytoin, cyclosporine, dihydropyridines, etc.
- \<Dental\>
- •Poor oral hygiene (PlI\>2) 28
- Subjects will be exited from the study immediately upon:
- Change of mind regarding participation
- Development of acute dental/oral conditions requiring treatment
- Development of a condition requiring treatment that conflicts with the exclusion criteria listed above
- Failure to comply with study instructions/requirements/appointments
- B) Target population: Operators
- Inclusion criteria
- •2nd and 3rd year residents at Division of Periodontology, The Ohio State University, in good standing.
- Exclusion criteria
- •Residents who don't want to participate in the study.
Exclusion
Key Trial Info
Start Date :
December 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04099680
Start Date
December 31 2020
End Date
April 15 2025
Last Update
May 10 2024
Active Locations (1)
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1
The Ohio State University College of Dentistry
Columbus, Ohio, United States, 43210