Concentrated Growth Factor in the Treatment of Gingival Recessions
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concentrated Growth Factor Membrane
Coronally Advanced Flap
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Multiple gingival recession, Concentrated growth factor, Coronally advanced flap
Eligibility Criteria
Inclusion Criteria:
- systemically and periodontally healthy,
- non-smokers
- presence of ≥ 2 buccal adjacent Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth <3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch
- width of keratinized gingiva ≥ 2mm
- presence of identifiable cemento-enamel junction
- full-mouth plaque index (PI) < 20 % and gingival index (GI) scores <1,
- presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area,
Exclusion Criteria:
- patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion,
- previous surgery in the defects area within the past 1 year,
- pregnant or lactating females
- drug and alcohol abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Concentrated growth Factor Membrane
Coronally Advanced Flap
Arm Description
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Periodontal plastic surgery procedure in the treatment of gingival recession
Outcomes
Primary Outcome Measures
Complete root coverage
Change from baseline in percentage of complete root coverage at 6th months.
Secondary Outcome Measures
Percentage root coverage
Change from baseline in percentage of root coverage at at 6th months.
Keratinized gingiva width
The distance is from the mucogingival junction (MGJ) to the gingival margin
Recession depth
The distance is from the cemento-enamel junction to the gingival margin
Gingival Thickness
Probing depth
The distance is from the gingival margin to the bottom of the sulcus
Clinical attachment loss
The distance is from the cemento-enamel junction to the bottom of the sulcus.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02385734
Brief Title
Concentrated Growth Factor in the Treatment of Gingival Recessions
Official Title
Concentrated Growth Factor Membrane in the Treatment of Adjacent Multiple Gingival Recessions: A Split Mouth Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study hypothesized that Concentrated Growth Factors'(CGF) placement together with Coronally Advanced Flap (CAF) may enhance the healing of soft tissues. Therefore, the aim of this study was to determine the clinical effect of CGF combination with CAF compared to CAF alone in the treatment of adjacent multiple gingival recessions.
Detailed Description
The gingival recessions have been successfully treated by several periodontal plastic surgery procedures. Among the different types of procedures used, Coronally Advanced Flap (CAF) was the most frequent approach, and when combined with a connective tissue graft is accepted as a gold standard therapy. Recently, investigators reported the use of CGF in the reconstruction of bone defects. They concluded that bone formation had significantly increased by using CGF It has been used to accelerate new bone formation associated with guided bone regeneration in sinus augmentation.They stated that CGF may have a better regenerative capacity and high versatility. Therefore, this study hypothesized that CGFs' placement together with CAF may enhance the healing of soft tissues. Therefore, the aim of this study was to determine the clinical effect of CGF combination with CAF compared to CAF alone in the treatment of adjacent multiple gingival recessions.
The patients of this randomized, split mouth and controlled clinical trial study protocol were selected from individuals referred to the Department of Periodontology, at Faculty of Dentistry, Bülent Ecevit University, for either dentin hypersensitivity or aesthetic complaints between April 2013 and April 2014.
All the subjects received oral hygiene instructions and full-mouth scaling were performed 1 month before surgery. They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra soft toothbrush. In twenty subjects (mean age 37.10 ±1.03, 20-45years, 13 females, 7 males), one side of the jaw received CAF (control sites)( 59 defects), the opposite site received CAF+CGF (test sites) (60 defects).
Full-mouth Plaque index and Gingival index were evaluated before surgery. Custom acrylic guides were fabricated to measure the clinical parameters at the mid-buccal aspect of the treated teeth.Probing depth (PD), Clinical Attachment Loss (CAL),Recession Depth (RD),Keratinized Gingiva Width (KGW) were recorded at the mid-buccal aspect of the treated teeth. Gingival Thickness (GT) was evaluated mid-facially, 2mm apical to the gingival margin at the attached gingiva or the alveolar mucosa, using a 20 endodontic reamer attached to a rubber stopper under the local anesthesia. After carefully removing the reamer, GT was measured with a digital caliper with 0.05 resolution PD, CAL, RD, KGW and GT were assessed at baseline and 6th months. Complete root coverage (CRC)and Percentage Root Coverage(PRC) were calculated at 6th months.
Intravenous blood was collected and placed into two different a 10mL glass-coated plastic tube without anticoagulant solutions. These tubes were then immediately centrifuged with a CGF centrifuge machine. The CGF clot was removed from the tube and separated from the Red Blood Cell by using microsurgical scissors. The CGF was squeezed in a special box that produces membranes at a constant thickness of 1mm.CGF membrane was immediately placed over the recession area.
All surgeries were performed by the same expert periodontist during a single surgical session Gingival recession sites were randomly determined as either test or control site by tossing a coin immediately before the surgical procedure.
Sutures were removed after 10 days and plaque control was maintained by CHX for additional 2 weeks. The patients started brush the tooth at the end of the 3rd week and they were again instructed in mechanical tooth cleaning of the treated tooth using an ultra soft toothbrush and roll technique. Oral hygiene instructions were provided at each postoperative visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Multiple gingival recession, Concentrated growth factor, Coronally advanced flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concentrated growth Factor Membrane
Arm Type
Experimental
Arm Description
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Arm Title
Coronally Advanced Flap
Arm Type
Active Comparator
Arm Description
Periodontal plastic surgery procedure in the treatment of gingival recession
Intervention Type
Other
Intervention Name(s)
Concentrated Growth Factor Membrane
Other Intervention Name(s)
An agent of platelet concentrates
Intervention Description
Concentrated growth factor membrane is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
Intervention Type
Procedure
Intervention Name(s)
Coronally Advanced Flap
Intervention Description
Periodontal plastic surgery technique
Primary Outcome Measure Information:
Title
Complete root coverage
Description
Change from baseline in percentage of complete root coverage at 6th months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage root coverage
Description
Change from baseline in percentage of root coverage at at 6th months.
Time Frame
6 months
Title
Keratinized gingiva width
Description
The distance is from the mucogingival junction (MGJ) to the gingival margin
Time Frame
6 months
Title
Recession depth
Description
The distance is from the cemento-enamel junction to the gingival margin
Time Frame
6 th months
Title
Gingival Thickness
Time Frame
6 months
Title
Probing depth
Description
The distance is from the gingival margin to the bottom of the sulcus
Time Frame
6 months
Title
Clinical attachment loss
Description
The distance is from the cemento-enamel junction to the bottom of the sulcus.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
systemically and periodontally healthy,
non-smokers
presence of ≥ 2 buccal adjacent Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth <3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch
width of keratinized gingiva ≥ 2mm
presence of identifiable cemento-enamel junction
full-mouth plaque index (PI) < 20 % and gingival index (GI) scores <1,
presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area,
Exclusion Criteria:
patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion,
previous surgery in the defects area within the past 1 year,
pregnant or lactating females
drug and alcohol abuse
12. IPD Sharing Statement
Learn more about this trial
Concentrated Growth Factor in the Treatment of Gingival Recessions
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