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Gingival RecessionNCT02385734

Concentrated Growth Factor in the Treatment of Gingival Recessions

A study testing Concentrated Growth Factor Membrane and Coronally Advanced Flap in people with Gingival Recession, run by Bulent Ecevit University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Concentrated Growth Factor Membrane and Coronally Advanced Flap
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Apr 2013to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Concentrated Growth Factor Membrane, Coronally Advanced Flap
Keywords
Multiple gingival recession, Concentrated growth factor, Coronally advanced flap
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concentrated Growth Factor MembraneOther

    Also called An agent of platelet concentrates

    Concentrated growth factor membrane is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix

  • Coronally Advanced FlapProcedure or surgery

    Periodontal plastic surgery technique

Study groups in NCT02385734
Study groupRoleWhat they receive
Concentrated growth Factor MembraneExperimentalAutogenous platelet and leukocyte fibrin material was obtained from blood.
Receives: Other: Concentrated Growth Factor Membrane; Procedure: Coronally Advanced Flap
Coronally Advanced FlapActive comparatorPeriodontal plastic surgery procedure in the treatment of gingival recession
Receives: Procedure: Coronally Advanced Flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete root coverage

    Change from baseline in percentage of complete root coverage at 6th months.

    Measured: 6 months

Secondary outcomes (6)
  1. Percentage root coverage

    Change from baseline in percentage of root coverage at at 6th months.

    Measured: 6 months

  2. Keratinized gingiva width

    The distance is from the mucogingival junction (MGJ) to the gingival margin

    Measured: 6 months

  3. Recession depth

    The distance is from the cemento-enamel junction to the gingival margin

    Measured: 6 th months

  4. Gingival Thickness

    Measured: 6 months

  5. Probing depth

    The distance is from the gingival margin to the bottom of the sulcus

    Measured: 6 months

  6. Clinical attachment loss

    The distance is from the cemento-enamel junction to the bottom of the sulcus.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385734
Sponsor's protocol ID
2013-62550515-03
Status last verified
Mar 2015
First submitted
2 Mar 2015
Last updated
11 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Concentrated Growth Factor Membrane and Coronally Advanced Flap in people with Gingival Recession, run by Bulent Ecevit University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete root coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.

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