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The Effectiveness of Different Methods for Healing a Palatal Donor Site

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ClinicalTrials.gov Identifier: NCT03567148
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sıla Çağrı İşler, Gazi University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wound Heal Graft Pain Palate; Wound Procedure: PRF Procedure: Essix retainer Procedure: Ozone therapy Procedure: LLLT Procedure: Collagen fleece Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of The Effectiveness of Different Methods for Healing a Palatal Donor Site After Harvesting a Free Gingival Graft
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PRF group
Four layers of PRF membranes were placed in the palatal wound and sutured with 5/0 resorbable sutures
 Procedure: PRF
Applying to the palatal wounds
Other Name: medical device
Active Comparator: Essix retainer group
An impression of palatal region was taken and the Essix retainer was prepared before the patients underwent surgery.
 Procedure: Essix retainer
Applying to the palatal wounds
Other Name: medical device
Active Comparator: Ozone therapy group
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
Applying to the palatal wounds
Other Name: medical device
Active Comparator: LLLT group
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
Applying to the palatal wounds
Other Name: medical device
Active Comparator: Collagen fleece group
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
Applying to the palatal wounds
Other Name: medical device
No Intervention: Control group
Palatal wounds were left for spontaneous healing


Outcome Measures
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Primary Outcome Measures :
  1. VAS questionnaire regarding to postoperative pain [ Time Frame: 30th days postoperatively ]
    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


Secondary Outcome Measures :
  1. VAS questionnaire regarding to postoperative sensitivity [ Time Frame: 30th days postoperatively ]
    The VAS was divided into 10 segments, and the patients were asked to rank their sensitivity level using a scoring system ranging from 0 to 10

  2. hydrogen peroxide test [ Time Frame: 30th days postoperatively ]
    Epithelization was evaluated using the same time-points by means of bubble formation after dripping hydrogen peroxide (3%) onto the operation site

  3. VAS questionnaire regarding to changes in eating habits [ Time Frame: 30th days postoperatively ]
    The VAS was divided into 10 segments, and the patients were asked to rank their eating habits level using a scoring system ranging from 0 to 10

  4. VAS questionnaire regarding to burning sensation [ Time Frame: 30th days postoperatively ]
    The VAS was divided into 10 segments, and the patients were asked to rank their sense of burning level using a scoring system ranging from 0 to 10


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567148


Sponsors and Collaborators
Gazi University
Investigators
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Study Director: Deniz Cetiner, Prof. Dr. Gazi University
More Information
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Publications:

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Responsible Party: Sıla Çağrı İşler, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier: NCT03567148    
Other Study ID Numbers: 36290600/114
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sıla Çağrı İşler, Gazi University:
Graft
Pain
Palate
Wound healing
Additional relevant MeSH terms:
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Wounds and Injuries