Clinical trial NCT03567148: The Effectiveness of Different Methods for Healing a Palatal Donor Site
Official title: Evaluation of The Effectiveness of Different Methods for Healing a Palatal Donor Site After Harvesting a Free Gingival Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Graft Pain
Palate; Wound
Keywords: Graft
Pain
Palate
Wound healing
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative complications associated with free gingival graft (FGG) procedures are prolonged bleeding from the donor site, postoperative pain and delayed wound healing which increases the patients' morbidity. Hence, the aim of this study is to assess the effectiveness of different treatment modalities on palatal wound healing and patient's morbidity after FGG. Ninety patients requiring FGG were randomly will be assigned into six groups: group 1: Platelet rich fibrin (PRF) membrane, group 2: Essix retainer, group 3: topical ozone therapy, group 4: low-level laser therapy (LLLT), group 5: collagen fleece and group 6: untreated control group. Epithelization will be evaluated by means of bubble formation; sensitivity, edema, pain, changes in eating habits and burning sensation will be assessed by using visual analog scale (VAS) and also the presence of discomfort and bleeding will be evaluated in the postoperative first week and at 14 days, 1 and 3 months postoperatively.

Detailed description: Inadequate attached gingiva is one of the major mucogingival problems for many individuals. However, the width of the keratinized tissue required to prevent periodontal disease remains unclear. Recently, a consensus report highlighted that if an individual's plaque control is suboptimal, a minimum of 2 mm of keratinized tissue and 1 mm of attached gingiva is needed.

Palatal keratinized mucosa is the most favorable donor region for a free gingival graft (FGG) due to its anatomic properties such as being histologically identical to keratinized attached mucosa of alveolar ridge and its ideal tissue thickness. The FGG surgical wound heals within 2-4 weeks, and prolonged bleeding, pain, and delayed wound healing of either the donor or recipient sites, which increases the patient's risk of morbidity, are the most common postoperative complications following surgery. Although homeostatic agents, mechanical barriers, and bioactive materials have been found to be effective in preventing these complications, the most ideal treatment has not yet been determined.

Platelet-rich fibrin (PRF), a platelet concentrate, is a safe and cost-effectiveness procedure that does not require biochemical blood handling. PRF has been used in many fields as an autologous biomaterial with a great healing potential for regenerating soft tissue and bones without inflammatory reactions, and it may be used to promote hemostasis and wound healing due to the presence of many growth factors. Recent studies have concluded that using PRF membranes after harvesting FGG enhances wound healing, reduces a patient's discomfort, and decreases need to change eating habits; thus, it reduces patient morbidity.

An Essix® retainer (Clear Advantage Series, Ortho Technology, Florida, USA) is a thermoplastic material used for stabilization after orthodontic treatment. It has been reported that gingival wounds that heal by secondary intention should be sheltered during the period of epithelization to protect against topical irritants, trauma, acidic or highly seasoned foods, and toothbrush abrasion.

It has been suggested that hemostatic agents provide faster and continuous hemostasis and make a positive contribution to early soft tissue healing. Application of hemostatic agents to the palatal donor sites has been found to be highly beneficial for achieving hemostasis in comparison to pressure only. Collagen fleece is a hemostatic agent that is made from the natural collagen of porcine dermis. The structure of the collagen promotes the formation and stabilization of blood clots during the initial wound healing phase. Recently, collagen-based materials have been used to improve early wound healing with an open healing design in the palatal area.

Ozone is a natural gaseous molecule made up of three oxygen atoms. The use of ozone has been proposed in dentistry because of its a strong oxidation effect and its antimicrobial potential, biocompatibility, and healing properties. In a previous study, the application of ozonated oil was reported to improve epithelial healing and gingival health following topical application. Taşdemir et al. concluded that ozone therapy could enhance wound healing, and the patients receiving this therapy experienced less pain after FGG operations than patients that had not received it.

Lower-level laser therapy (LLLT) is known as 'soft laser therapy' or 'bio-stimulation'. In dentistry, LLLT is usually used to accelerate wound healing, enhance remodeling and repair of bone, and reduce pain. Application of LLLT has been shown to improve wound healing after FGG and gingivectomy.

In light of this aforementioned information, it has been hypothesized that applications of PRF, an Essix retainer, collagen fleece, ozone therapy, and LLLT can result in improved wound healing after harvesting FGG in comparison to spontaneous healing. Thus, the present study aimed to assess and compare the effectiveness of these methods on palatal wound healing and patient morbidity.

Eligibility criteria: Inclusion Criteria:

* age \>18,
* systemically healthy,
* non-smoker,
* full-mouth plaque and bleeding scores \<20%,
* isolated gingival recession defects on the mandibular and maxillary anterior teeth with insufficient keratinized gingiva,

Exclusion Criteria:

* history of mucogingival surgery on the palatal area
* pregnancy
* systemic antibiotics taken for at least six months before the study
* having systemic diseases that could compromise wound healing

Primary outcomes:
measure: VAS questionnaire regarding to postoperative pain
timeFrame: 30th days postoperatively
Secondary outcomes:
measure: VAS questionnaire regarding to postoperative sensitivity
timeFrame: 30th days postoperatively
measure: hydrogen peroxide test
timeFrame: 30th days postoperatively
measure: VAS questionnaire regarding to changes in eating habits
timeFrame: 30th days postoperatively
measure: VAS questionnaire regarding to burning sensation
timeFrame: 30th days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Deniz Cetiner, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.
citation: Harrison JS, Conlan MJ, Deas DE. An alternative donor site for an epithelialized-free soft-tissue autograft. Compend Contin Educ Dent. 2011 Mar;32(2):e29-31.
citation: Kim DM, Neiva R. Periodontal soft tissue non-root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S56-72. doi: 10.1902/jop.2015.130684.
citation: Sanz M, Simion M; Working Group 3 of the European Workshop on Periodontology. Surgical techniques on periodontal plastic surgery and soft tissue regeneration: consensus report of Group 3 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S92-7. doi: 10.1111/jcpe.12215.
citation: Brasher WJ, Rees TD, Boyce WA. Complications of free grafts of masticatory mucosa. J Periodontol. 1975 Mar;46(3):133-8. doi: 10.1902/jop.1975.46.3.133.
citation: Keceli HG, Aylikci BU, Koseoglu S, Dolgun A. Evaluation of palatal donor site haemostasis and wound healing after free gingival graft surgery. J Clin Periodontol. 2015 Jun;42(6):582-9. doi: 10.1111/jcpe.12404. Epub 2015 May 19.
citation: Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
citation: Borie E, Olivi DG, Orsi IA, Garlet K, Weber B, Beltran V, Fuentes R. Platelet-rich fibrin application in dentistry: a literature review. Int J Clin Exp Med. 2015 May 15;8(5):7922-9. eCollection 2015.
citation: Kulkarni MR, Thomas BS, Varghese JM, Bhat GS. Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 May;18(3):399-402. doi: 10.4103/0972-124X.134591.
citation: Femminella B, Iaconi MC, Di Tullio M, Romano L, Sinjari B, D'Arcangelo C, De Ninis P, Paolantonio M. Clinical Comparison of Platelet-Rich Fibrin and a Gelatin Sponge in the Management of Palatal Wounds After Epithelialized Free Gingival Graft Harvest: A Randomized Clinical Trial. J Periodontol. 2016 Feb;87(2):103-13. doi: 10.1902/jop.2015.150198. Epub 2015 Aug 27.
citation: Rossmann JA, Rees TD. A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding. J Periodontol. 1999 Nov;70(11):1369-75. doi: 10.1902/jop.1999.70.11.1369.
citation: Silverstein ME, Chvapil M. Experimental and clinical experiences with collagen fleece as a hemostatic agent. J Trauma. 1981 May;21(5):388-93. doi: 10.1097/00005373-198105000-00011.
citation: Thoma DS, Hilbe M, Bienz SP, Sancho-Puchades M, Hammerle CH, Jung RE. Palatal wound healing using a xenogeneic collagen matrix - histological outcomes of a randomized controlled clinical trial. J Clin Periodontol. 2016 Dec;43(12):1124-1131. doi: 10.1111/jcpe.12624. Epub 2016 Oct 25.
citation: Nogales CG, Ferrari PH, Kantorovich EO, Lage-Marques JL. Ozone therapy in medicine and dentistry. J Contemp Dent Pract. 2008 May 1;9(4):75-84.
citation: Patel PV, Kumar V, Kumar S, Gd V, Patel A. Therapeutic effect of topical ozonated oil on the epithelial healing of palatal wound sites: a planimetrical and cytological study. J Investig Clin Dent. 2011 Nov;2(4):248-58. doi: 10.1111/j.2041-1626.2011.00072.x. Epub 2011 Jul 7.
citation: Tasdemir Z, Alkan BA, Albayrak H. Effects of Ozone Therapy on the Early Healing Period of Deepithelialized Gingival Grafts: A Randomized Placebo-Controlled Clinical Trial. J Periodontol. 2016 Jun;87(6):663-71. doi: 10.1902/jop.2016.150217. Epub 2016 Jan 16.
citation: Aggarwal H, Singh MP, Nahar P, Mathur H, Gv S. Efficacy of low-level laser therapy in treatment of recurrent aphthous ulcers - a sham controlled, split mouth follow up study. J Clin Diagn Res. 2014 Feb;8(2):218-21. doi: 10.7860/JCDR/2014/7639.4064. Epub 2014 Feb 3.
citation: Ustaoglu G, Ercan E, Tunali M. Low-Level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness at Free Gingival Graft Donor Sites: A Randomized, Controlled Clinical Study. Photomed Laser Surg. 2017 Apr;35(4):223-230. doi: 10.1089/pho.2016.4163. Epub 2017 Jan 12.
citation: Ozcelik O, Cenk Haytac M, Kunin A, Seydaoglu G. Improved wound healing by low-level laser irradiation after gingivectomy operations: a controlled clinical pilot study. J Clin Periodontol. 2008 Mar;35(3):250-4. doi: 10.1111/j.1600-051X.2007.01194.x.