Clinical trial NCT04099680: Free Gingival Grafts (FGGs) in Mandibular Posterior Sites
Official title: Free Gingival Grafts (FGGs) in Mandibular Posterior Sites: A Randomized Clinical Trials of Wound Healing Following Different Recipient Bed Preparations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lack of Keratinized Tissue
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 13
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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:

1. 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.
2. To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.

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 bed for a graft tissue is done with partial-thickness flap elevation, in which part of the mucosa and submucosa, but not the periosteum (dense fibrous membrane covering the surface of bones), are separated from underneath bone. In the traditional method of gum bed preparation, separation of the mucosa and submucosa from underneath periosteum and bone should be done with extremely caution to avoid damaging the periosteum. Therefore, the traditional method of gum bed preparation is not only time consuming but also problematic because of more bleeding when compared to full thickness flap elevation, in which the mucosa and submucosa together with the periosteum are separated from underneath bone. In order to stabilize gum graft on bone surface, a new technique is applied in this study by using two bone screws as anchorage to fastened the graft on the exposed bone through suturing. In the present study, we will compare patient quality of life, operator satisfaction, and differences in surgical wound healing between these two different bed preparations. The results of this study could help establish a more patient- and operator-friendly surgical protocol for the use of gum graft to increase the width of keratinized oral mucosa.

Eligibility criteria: 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.

Primary outcomes:
measure: Graft width, length and area
timeFrame: During the surgery, at the 1-, 2-, 4-, 8- week visits
Secondary outcomes:
measure: Wound healing index
timeFrame: At the 3-day, 1-, 2-, 4-, 8- week visits
measure: Graft thickness
timeFrame: During the surgery, at the 8-week visits
measure: Graft mobility
timeFrame: At the end of surgery, at the 8-week visits
measure: Biochemical wound assessment
timeFrame: At the 3-day, 1-, 2- week visits
measure: Surgical time
timeFrame: During the surgery
measure: Pain assessment.
timeFrame: At the 3-day, 1-, 2-, 4-, 8- week visits
measure: OHIP-14
timeFrame: Right before the surgery and at the 3-day, 1-, 2-, 4-, 8- week visits
measure: Operator-centered outcomes
timeFrame: Immediately after the surgery, 2-week post-op visit and when an operator has conducted all allocated cases
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Dentistry
state: Ohio
Study officials:
affiliation: The Ohio State University Graduate Periodontics Program Director
name: Tatakis Dimitris, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Nabers JM. Free gingival grafts. Periodontics. 1966 Sep-Oct;4(5):243-5. No abstract available.
citation: Sullivan HC, Atkins JH. Free autogenous gingival grafts. I. Principles of successful grafting. Periodontics. 1968 Jun;6(3):121-9. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Martin W, Lewis E, Nicol A. Local risk factors for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:28-38.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Egbewale BE. Random allocation in controlled clinical trials: a review. J Pharm Pharm Sci. 2014;17(2):248-53. doi: 10.18433/j3sw36.
citation: 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.
citation: 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.
citation: Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
citation: 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.
citation: 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.