NCT03567148

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

May 16, 2018

Last Update Submit

June 12, 2018

Conditions

Wound HealGraft PainPalate; Wound

Keywords

GraftPainPalateWound healing

Outcome Measures

Primary Outcomes (1)

  • VAS questionnaire regarding to postoperative pain

    The VAS was divided into 10 segments, and the patients were asked to rank their pain level using a scoring system ranging from 0 to 10

    30th days postoperatively

Secondary Outcomes (4)

  • VAS questionnaire regarding to postoperative sensitivity

    30th days postoperatively

  • hydrogen peroxide test

    30th days postoperatively

  • VAS questionnaire regarding to changes in eating habits

    30th days postoperatively

  • VAS questionnaire regarding to burning sensation

    30th days postoperatively

Study Arms (6)

PRF group

ACTIVE COMPARATOR

Four layers of PRF membranes were placed in the palatal wound and sutured with 5/0 resorbable sutures

Procedure: PRF

Essix retainer group

ACTIVE COMPARATOR

An impression of palatal region was taken and the Essix retainer was prepared before the patients underwent surgery.

Procedure: Essix retainer

Ozone therapy group

ACTIVE COMPARATOR

Ozone was applied to the donor sites at five different points (four corner-points and a center point) at a fixed concentration of 2100 p.p.m. through a connected hand-piece, using a sterile, specially-formed perio-tip with 80% oxygen for 30 seconds. The applications were performed immediately after surgery and on the 1st, 3rd, and 7th days following the operation.

Procedure: Ozone therapy

LLLT group

ACTIVE COMPARATOR

Irradiation was performed at the same points described above using a diode laser (λ=970±15 nm, 14-W source power) (SIROLaser Xtend; Sirona Dental Systems GmbH, Bensheim, Germany) that continuously emitted a wavelength with 320µm fiberoptic; the power was 2W and the tissue dose was 35 J/cm2. Total irradiation time was 30 seconds. The applications were performed immediately after surgery, and on the 1st, 3rd and 7th, days following the operation.

Procedure: LLLT

Collagen fleece group

ACTIVE COMPARATOR

Collagen fleece (BEGO Collagen Fleece, Bremen, Germany) was sutured with 5/0 resorbable sutures (Pegesorb, Istanbul, Turkey) on the open wound with the aid of vertical mattress sutures.

Procedure: Collagen fleece

Control group

NO INTERVENTION

Palatal wounds were left for spontaneous healing

Interventions

PRFPROCEDURE

Applying to the palatal wounds

Also known as: medical device
PRF group
Essix retainerPROCEDURE

Applying to the palatal wounds

Also known as: medical device
Essix retainer group
Ozone therapyPROCEDURE

Applying to the palatal wounds

Also known as: medical device
Ozone therapy group
LLLTPROCEDURE

Applying to the palatal wounds

Also known as: medical device
LLLT group
Collagen fleecePROCEDURE

Applying to the palatal wounds

Also known as: medical device
Collagen fleece group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • 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.

    PMID: 24494804BACKGROUND

  • 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.

    PMID: 23738833BACKGROUND

  • 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.

    PMID: 25644300BACKGROUND

  • 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.

    PMID: 24641004BACKGROUND

  • 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.

    PMID: 1079047BACKGROUND

  • 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.

    PMID: 25892528BACKGROUND

  • 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.

    PMID: 16504849BACKGROUND

  • 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.

    PMID: 26221349BACKGROUND

  • 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.

    PMID: 25024559BACKGROUND

  • 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.

    PMID: 26313017BACKGROUND

  • 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.

    PMID: 10588501BACKGROUND

  • 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.

    PMID: 7230285BACKGROUND

  • 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.

    PMID: 27616435BACKGROUND

  • 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.

    PMID: 18473030BACKGROUND

  • 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.

    PMID: 25426896BACKGROUND

  • 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.

    PMID: 26777769BACKGROUND

  • 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.

    PMID: 24701539BACKGROUND

  • 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.

    PMID: 28092488BACKGROUND

  • 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.

    PMID: 18269665BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesPain

Interventions

Equipment and SuppliesLow-Level Light TherapyCollagen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyBiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Deniz Cetiner, Prof. Dr.

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2018

First Posted

June 25, 2018

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06