The Effectiveness of Different Methods for Healing a Palatal Donor Site

June 12, 2018 updated by: Sıla Çağrı İşler, Gazi University

Evaluation of The Effectiveness of Different Methods for Healing a Palatal Donor Site After Harvesting a Free Gingival Graft

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • medical device
NO_INTERVENTION: Control group
Palatal wounds were left for spontaneous healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30th days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30th days postoperatively
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
30th days postoperatively
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
30th days postoperatively
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
30th days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Director: Deniz Cetiner, Prof. Dr., Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (ACTUAL)

June 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36290600/114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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