- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04099680
Free Gingival Grafts (FGGs) in Mandibular Posterior Sites
Free Gingival Grafts (FGGs) in Mandibular Posterior Sites: A Randomized Clinical Trials of Wound Healing Following Different Recipient Bed Preparations
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 preparation sites. Currently, no information is available on free gingival graft treatment outcomes comparing full thickness recipient bed preparation, i.e., no periosteum remaining under the free gingival graft, with the aid of bone screws versus a conventional partial thickness recipient bed preparation with periosteum remaining under the graft. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft to increase the width of keratinized gingival tissue in mandibular posterior sites. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft procedure to increase the width of keratinized gingival tissue in mandibular posterior sites. The specific aims of this research study contain two aspects:
- To compare the wound healing of a free gingival graft using either a partial thickness flap or full-thickness flap preparation with bone screws at the recipient site around mandibular posterior areas.
- To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hua-Hong Chien, DDS, PhD
- Phone Number: 614-292-0371
- Email: chien.60@osu.edu
Study Contact Backup
- Name: Ying Wang, DDS
- Phone Number: 614-664-3785
- Email: wang.10981@osu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Partial-thickness bed preparation
Partial-thickness bed preparation for free gingival graft procedure.
|
Flap will be separated by sharp dissection and elevated toward apical direction, leaving the periosteum covering the bone, and the elevated pedicle flap will be incised and removed.
Interrupted periosteal sutures placed at the 4 corners of each graft, and mesial and distal surfaces to engage the graft at an equidistance from the graft corners.
Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and the periosteum apically.
|
Experimental: Full-thickness bed preparation
Full-thickness bed preparation with bone screw placement for anchoring the sutures.
|
Interrupted periosteal sutures placed at the 4 corners of each graft, and mesial and distal surfaces to engage the graft at an equidistance from the graft corners.
Full-thickness (mucoperiosteal) flap will be raised on the recipient bed to establish a denuded bone area.
Two bone screws will be placed at the most apical border of the denuded bone.
Two bone screws placed at the most apical border of the denuded bone after osteotomy.
Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and each is apically looped around the corresponding apically positioned screw.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft width, length and area
Time Frame: During the surgery, at the 1-, 2-, 4-, 8- week visits
|
Graft length and width will be confirmed after harvest and remeasured in situ, using a digital caliper, after completion of the surgical procedure.
Subsequently, graft length and width will be measured on clinical images obtained at the post-op visits.
A mirror image photo of the grafted site will be taken with a single-lens reflex camera and the dimension will be measured and analyzed with Image J software.
Size markers will be used to calibrate image magnification.
Graft area will be calculated from the length and width measurements.
|
During the surgery, at the 1-, 2-, 4-, 8- week visits
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound healing index
Time Frame: At the 3-day, 1-, 2-, 4-, 8- week visits
|
Clinical photographs of the recipient sites will be taken at baseline, immediately after surgery, and at each follow-up visit, to record the appearance of the graft.
A size marker will be used to standardize photos.
Small size mirror will be placed with caution to avoid any disturbance of the surgical site, and mirror image photo will be taken.
Wound healing index by Pippi et al. , which is the modified Wound Healing Index by Landry et al., is customized and used to evaluate the healing potential of the graft.
|
At the 3-day, 1-, 2-, 4-, 8- week visits
|
Graft thickness
Time Frame: During the surgery, at the 8-week visits
|
Graft thickness will be measured in situ with digital caliper, and at the 8-week follow-up visit using an endodontic reamer, at five (5) predetermined points.
A central point will be located at the geometric center of the graft, where the two diagonals of the square intersect.
The other four points will each be located on the diagonal, at 3 mm from the corner of the graft.
Pre-fabricated acrylic stent with holes for the measurements will be used to standardize measurement location.
At 8 weeks, graft thickness measurements will be repeated following topical and local anesthesia using infiltration.
|
During the surgery, at the 8-week visits
|
Graft mobility
Time Frame: At the end of surgery, at the 8-week visits
|
At the end of the procedure, graft mobility will be assessed indirectly and graded.
While exerting tension on the cheek/vestibule, graft will be observed for mobility.
Mobility will be graded indirectly, by exerting tension on the cheek/vestibule, and directly, by applying gentle force on the graft using a periodontal probe, in a manner similar to the functional approach used to locate the mucogingival junction.
|
At the end of surgery, at the 8-week visits
|
Biochemical wound assessment
Time Frame: At the 3-day, 1-, 2- week visits
|
Wound fluid will be collected from the transplanted graft site.
Paper strips will be left in place for 30 sec and then immediately transferred to a micro-moisture meter to determine the volume of collected fluid.
Following volume measurement, paper strips will be immediately placed into a vial, on ice; fluid collection will be repeated after 5 minutes.
Then the vial with the 4 paper strips will be transferred to a -80˚C freezer until further analysis.
Expression of angiogenesis biomarkers will be quantified with the use of a human angiogenesis custom array kit according to the manufacturer's protocol.
|
At the 3-day, 1-, 2- week visits
|
Surgical time
Time Frame: During the surgery
|
Length of surgery will be measured at the time the operator starts the first incision in the recipient bed and stopped when the last suture placement is placed.
Bed preparation and graft placement will be independently timed to compare between procedures and with operator's opinion.
|
During the surgery
|
Pain assessment.
Time Frame: At the 3-day, 1-, 2-, 4-, 8- week visits
|
A visual analogue scale (VAS) will be used to measure daily pain intensity at each postoperative week.
The self-reported degree of pain will be scored, with 0 defined as the absence of pain and 10 as the maximum tolerable level of pain.
The intake of NSAIDs will be also recorded. .
|
At the 3-day, 1-, 2-, 4-, 8- week visits
|
OHIP-14
Time Frame: Right before the surgery and at the 3-day, 1-, 2-, 4-, 8- week visits
|
The oral health-related quality of life will be assessed by the Oral Health Impact Profile scale (OHIP-14).
Participants will be asked how frequently they had experienced the impact on each category in OHIP-14 with a 5-point scale (from 0 to 4).
The total score of OHIP-14 will be calculated by adding the sum of each category from 14 questions (total score ranges from 0 to 56 points).
Higher scores imply a poorer oral health quality of life, whereas lower scores indicate a better one.
|
Right before the surgery and at the 3-day, 1-, 2-, 4-, 8- week visits
|
Operator-centered outcomes
Time Frame: Immediately after the surgery, 2-week post-op visit and when an operator has conducted all allocated cases
|
Immediately after the surgery, operators will receive custom questionnaire to assess the difficulty of the surgery. Each step of the surgery will be categorized and will be marked with 10-point scale (from 0 to 10) based on the surgical difficulty and time management. After completion of the 2-week post-op visit, operators will be asked to assess difficulty of screw removal (test group only). Also, after each enrolled operator has conducted all allocated cases (2 cases of full-thickness flap group and 2 cases of partial-thickness flap group, possibly up to 1 year.), including all 2-week post-op visits, he/she will be asked to report their preference of procedure (control or test) |
Immediately after the surgery, 2-week post-op visit and when an operator has conducted all allocated cases
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tatakis Dimitris, DDS, PhD, The Ohio State University Graduate Periodontics Program Director
Publications and helpful links
General Publications
- Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Thoma DS, Buranawat B, Hammerle CH, Held U, Jung RE. Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S77-91. doi: 10.1111/jcpe.12220.
- Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.
- Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x.
- Abrahamsson I, Berglundh T, Wennstrom J, Lindhe J. The peri-implant hard and soft tissues at different implant systems. A comparative study in the dog. Clin Oral Implants Res. 1996 Sep;7(3):212-9. doi: 10.1034/j.1600-0501.1996.070303.x.
- Wennstrom JL, Bengazi F, Lekholm U. The influence of the masticatory mucosa on the peri-implant soft tissue condition. Clin Oral Implants Res. 1994 Mar;5(1):1-8. doi: 10.1034/j.1600-0501.1994.050101.x.
- Nabers JM. Free gingival grafts. Periodontics. 1966 Sep-Oct;4(5):243-5. No abstract available.
- Sullivan HC, Atkins JH. Free autogenous gingival grafts. I. Principles of successful grafting. Periodontics. 1968 Jun;6(3):121-9. No abstract available.
- Sullivan HC, Atkins JH. Free autogenous gingival grafts. 3. Utilization of grafts in the treatment of gingival recession. Periodontics. 1968 Aug;6(4):152-60. No abstract available.
- Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. A four year report. J Periodontol. 1982 Jun;53(6):349-52. doi: 10.1902/jop.1982.53.6.349.
- Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
- Miyasato M, Crigger M, Egelberg J. Gingival condition in areas of minimal and appreciable width of keratinized gingiva. J Clin Periodontol. 1977 Aug;4(3):200-9. doi: 10.1111/j.1600-051x.1977.tb02273.x.
- Scheyer ET, Sanz M, Dibart S, Greenwell H, John V, Kim DM, Langer L, Neiva R, Rasperini G. Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S73-6. doi: 10.1902/jop.2015.140377.
- Gobbato L, Avila-Ortiz G, Sohrabi K, Wang CW, Karimbux N. The effect of keratinized mucosa width on peri-implant health: a systematic review. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1536-45. doi: 10.11607/jomi.3244.
- Brito C, Tenenbaum HC, Wong BK, Schmitt C, Nogueira-Filho G. Is keratinized mucosa indispensable to maintain peri-implant health? A systematic review of the literature. J Biomed Mater Res B Appl Biomater. 2014 Apr;102(3):643-50. doi: 10.1002/jbm.b.33042. Epub 2013 Oct 7.
- Adibrad M, Shahabuei M, Sahabi M. Significance of the width of keratinized mucosa on the health status of the supporting tissue around implants supporting overdentures. J Oral Implantol. 2009;35(5):232-7. doi: 10.1563/AAID-JOI-D-09-00035.1.
- Martin W, Lewis E, Nicol A. Local risk factors for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:28-38.
- Schrott AR, Jimenez M, Hwang JW, Fiorellini J, Weber HP. Five-year evaluation of the influence of keratinized mucosa on peri-implant soft-tissue health and stability around implants supporting full-arch mandibular fixed prostheses. Clin Oral Implants Res. 2009 Oct;20(10):1170-7. doi: 10.1111/j.1600-0501.2009.01795.x. Epub 2009 Aug 30.
- Jansen JA, de Wijn JR, Wolters-Lutgerhorst JM, van Mullem PJ. Ultrastructural study of epithelial cell attachment to implant materials. J Dent Res. 1985 Jun;64(6):891-6. doi: 10.1177/00220345850640060601.
- Ericsson I, Berglundh T, Marinello C, Liljenberg B, Lindhe J. Long-standing plaque and gingivitis at implants and teeth in the dog. Clin Oral Implants Res. 1992 Sep;3(3):99-103. doi: 10.1034/j.1600-0501.1992.030301.x.
- Lin GH, Chan HL, Wang HL. The significance of keratinized mucosa on implant health: a systematic review. J Periodontol. 2013 Dec;84(12):1755-67. doi: 10.1902/jop.2013.120688. Epub 2013 Mar 1.
- Dordick B, Coslet JG, Seibert JS. Clinical evaluation of free autogenous gengival grafts placed on alveolar bone. Part I. Clinical predictability. J Periodontol. 1976 Oct;47(10):559-67. doi: 10.1902/jop.1976.47.10.559.
- Caffesse RG, Burgett FG, Nasjleti CE, Castelli WA. Healing of free gingival grafts with and without periosteum. Part I. Histologic evaluation. J Periodontol. 1979 Nov;50(11):586-94. doi: 10.1902/jop.1979.50.11.586. No abstract available.
- James WC, McFall WT Jr. Placement of free gingival grafts on denuded alveolar bone. Part I: clinical evaluations. J Periodontol. 1978 Jun;49(6):283-90. doi: 10.1902/jop.1978.49.6.283.
- Nobuto T, Imai H, Yamaoka A. Microvascularization of the free gingival autograft. J Periodontol. 1988 Oct;59(10):639-46. doi: 10.1902/jop.1988.59.10.639.
- Yanagihara K. [Experimental studies on morphological changes of microvascular architecture following the free gingival autograft on denuded alveolar bone]. Nihon Shishubyo Gakkai Kaishi. 1990 Mar;32(1):45-70. doi: 10.2329/perio.32.45. Japanese.
- Egbewale BE. Random allocation in controlled clinical trials: a review. J Pharm Pharm Sci. 2014;17(2):248-53. doi: 10.18433/j3sw36.
- Pippi R, Santoro M, Cafolla A. The effectiveness of a new method using an extra-alveolar hemostatic agent after dental extractions in older patients on oral anticoagulation treatment: an intrapatient study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Jul;120(1):15-21. doi: 10.1016/j.oooo.2015.02.482. Epub 2015 Mar 2.
- Guglielmoni P, Promsudthi A, Tatakis DN, Trombelli L. Intra- and inter-examiner reproducibility in keratinized tissue width assessment with 3 methods for mucogingival junction determination. J Periodontol. 2001 Feb;72(2):134-9. doi: 10.1902/jop.2001.72.2.134.
- Landry R, Turnbull R, Rochette C. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-18.
- Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- fsafggrct2019
- 2019H0350 (Other Identifier: Ohio State University IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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