- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02385734
Concentrated Growth Factor in the Treatment of Gingival Recessions
Concentrated Growth Factor Membrane in the Treatment of Adjacent Multiple Gingival Recessions: A Split Mouth Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Concentrated growth Factor Membrane
Autogenous platelet and leukocyte fibrin material was obtained from blood.
|
Concentrated growth factor membrane is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
Other Names:
Periodontal plastic surgery technique
|
ACTIVE_COMPARATOR: Coronally Advanced Flap
Periodontal plastic surgery procedure in the treatment of gingival recession
|
Periodontal plastic surgery technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete root coverage
Time Frame: 6 months
|
Change from baseline in percentage of complete root coverage at 6th months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage root coverage
Time Frame: 6 months
|
Change from baseline in percentage of root coverage at at 6th months.
|
6 months
|
Keratinized gingiva width
Time Frame: 6 months
|
The distance is from the mucogingival junction (MGJ) to the gingival margin
|
6 months
|
Recession depth
Time Frame: 6 th months
|
The distance is from the cemento-enamel junction to the gingival margin
|
6 th months
|
Gingival Thickness
Time Frame: 6 months
|
6 months
|
|
Probing depth
Time Frame: 6 months
|
The distance is from the gingival margin to the bottom of the sulcus
|
6 months
|
Clinical attachment loss
Time Frame: 6 months
|
The distance is from the cemento-enamel junction to the bottom of the sulcus.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-62550515-03
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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