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The Effectiveness of Different Methods for Healing a Palatal Donor Site

Primary Purpose

Wound Heal, Graft Pain, Palate; Wound

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRF
Essix retainer
Ozone therapy
LLLT
Collagen fleece
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal focused on measuring Graft, Pain, Palate, Wound healing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    PRF group

    Essix retainer group

    Ozone therapy group

    LLLT group

    Collagen fleece group

    Control group

    Arm Description

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

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

    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.

    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.

    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.

    Palatal wounds were left for spontaneous healing

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    VAS questionnaire regarding to postoperative sensitivity
    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
    hydrogen peroxide test
    Epithelization was evaluated using the same time-points by means of bubble formation after dripping hydrogen peroxide (3%) onto the operation site
    VAS questionnaire regarding to changes in eating habits
    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
    VAS questionnaire regarding to burning sensation
    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

    Full Information

    First Posted
    May 16, 2018
    Last Updated
    June 12, 2018
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03567148
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Heal, Graft Pain, Palate; Wound
    Keywords
    Graft, Pain, Palate, Wound healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRF group
    Arm Type
    Active Comparator
    Arm Description
    Four layers of PRF membranes were placed in the palatal wound and sutured with 5/0 resorbable sutures
    Arm Title
    Essix retainer group
    Arm Type
    Active Comparator
    Arm Description
    An impression of palatal region was taken and the Essix retainer was prepared before the patients underwent surgery.
    Arm Title
    Ozone therapy group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    LLLT group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Collagen fleece group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Palatal wounds were left for spontaneous healing
    Intervention Type
    Procedure
    Intervention Name(s)
    PRF
    Other Intervention Name(s)
    medical device
    Intervention Description
    Applying to the palatal wounds
    Intervention Type
    Procedure
    Intervention Name(s)
    Essix retainer
    Other Intervention Name(s)
    medical device
    Intervention Description
    Applying to the palatal wounds
    Intervention Type
    Procedure
    Intervention Name(s)
    Ozone therapy
    Other Intervention Name(s)
    medical device
    Intervention Description
    Applying to the palatal wounds
    Intervention Type
    Procedure
    Intervention Name(s)
    LLLT
    Other Intervention Name(s)
    medical device
    Intervention Description
    Applying to the palatal wounds
    Intervention Type
    Procedure
    Intervention Name(s)
    Collagen fleece
    Other Intervention Name(s)
    medical device
    Intervention Description
    Applying to the palatal wounds
    Primary Outcome Measure Information:
    Title
    VAS questionnaire regarding to postoperative pain
    Description
    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
    Time Frame
    30th days postoperatively
    Secondary Outcome Measure Information:
    Title
    VAS questionnaire regarding to postoperative sensitivity
    Description
    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
    Time Frame
    30th days postoperatively
    Title
    hydrogen peroxide test
    Description
    Epithelization was evaluated using the same time-points by means of bubble formation after dripping hydrogen peroxide (3%) onto the operation site
    Time Frame
    30th days postoperatively
    Title
    VAS questionnaire regarding to changes in eating habits
    Description
    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
    Time Frame
    30th days postoperatively
    Title
    VAS questionnaire regarding to burning sensation
    Description
    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
    Time Frame
    30th days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deniz Cetiner, Prof. Dr.
    Organizational Affiliation
    Gazi University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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