Concentrated Growth Factor in the Treatment of Gingival Recessions

Gingival Recession Clinical Trial

Official title:

Concentrated Growth Factor Membrane in the Treatment of Adjacent Multiple Gingival Recessions: A Split Mouth Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385734
• Other study ID #: 2013-62550515-03
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 5, 2015
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Other:
• Concentrated Growth Factor Membrane
Concentrated growth factor membrane is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix

Procedure:
• Coronally Advanced Flap
Periodontal plastic surgery technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete root coverage	Change from baseline in percentage of complete root coverage at 6th months.	6 months	No
Secondary	Percentage root coverage	Change from baseline in percentage of root coverage at at 6th months.	6 months	No
Secondary	Keratinized gingiva width	The distance is from the mucogingival junction (MGJ) to the gingival margin	6 months	No
Secondary	Recession depth	The distance is from the cemento-enamel junction to the gingival margin	6 th months	No
Secondary	Gingival Thickness		6 months	No
Secondary	Probing depth	The distance is from the gingival margin to the bottom of the sulcus	6 months	No
Secondary	Clinical attachment loss	The distance is from the cemento-enamel junction to the bottom of the sulcus.	6 months	No