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Completed

NCT Number: NCT05319938

Growth Factors in the Treatment of the Multiple Gingival Recessions

The purpose of this study was to compare and evaluate the clinical effects of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique using a microsurgical approach in the treatment of Type I multiple gingival recessions (GR).

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Key information

Conditions

Growth Factors, Combined Defect of Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Figen Öngöz Dede

Ordu, 52100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systematically and periodontally healthy non-smokers
  • Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession depth, probing depth <3 mm and gingival thickness (GT) ≥ 0.8 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 %
  • Gingival index (GI) scores =1
  • Presence of tooth vitality
  • 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

Treatment and study plan

CAF only

Procedure

After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.

CAF+CGF

Procedure

After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.

Blood samples were collected into 10 ml glass-coated plastic tubes without anticoagulant solutions. These tubes were placed into CGF centrifuge machine and centrifuged immediately . CGF membrane were placed over the defect. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.

CAF+A-PRF

Procedure

After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.

Blood samples were collected into 10 ml glass-coated plastic tubes without anticoagulant solutions. These tubes were placed into A-PRF centrifuge machine and centrifuged immediately. A-PRF membrane were placed over the defect. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.

Primary outcomes

  1. Complete and mean root coverage

    Time frame: Change from baseline at 6 months of the percent of complete and mean root coverage

    Percentages of root coverage and complete root coverage were calculated according to the following standard formulae.

    Percentage of root coverage: [(preop. vertical gingival recession (VGR)- postop.VGR)\\ preop. VGR] x 100 Percentage of complete root coverage: [(teeth with complete root coverage) \\ (all treated teeth)] x 100.

Secondary outcomes

  1. Gingival thickness

    Time frame: Change from baseline at 6 months of the gingival thickness

    The gingival thickness was evaluated midbuccally in the attached gingival (GT-MB), halfway between the mucogingival junction and free gingival groove and at the base of the interdental papilla. GT was measured by using a periodontal probe with a rubber stopper under local anesthesia, and then the thickness was assessed by transferring to an electronic digital caliper.

  2. Keratinized gingiva width (WKG)

    Time frame: Change from baseline at 6 months of keratinized gingiva width

    The WKG was determined by subtracting the VGR from the CEJ- MGJ (mucogingival junction).

  3. Patient esthetic score (PES)

    Time frame: Change from baseline at 6 months of the patient esthetic score

    Patient esthetic score (PES) to evaluate esthetic appearance (color, appearance, and form of the selected site),

    PES: bad-unlikely esthetics (score 0) → perfect esthetics (score 10)

  4. Patient comfort score (PCS)

    Time frame: Change from baseline at 6 months of the patient comfort score

    Patient comfort score (PCS) for the pain, edema and other experiences regarding operating technique, instruments, and microscopic view, etc.

    PCS: unbearable discomfort (score 0) → no-discomfort (score 10).

  5. Hypersensitivity score (HS)

    Time frame: Change from baseline at 6 months of the hypersensitivity score

    "Hypersensitivity" score was recorded after blasting air (60 psi, 22°C) derived from a dental syringe that was heading for the root surface for 1 s. The syringe was held at 90° angle, 2-3 mm from the root surface. Neighboring teeth were shielded during testing with the dentist's gloved fingers; then the patient has enquired again to score the discomfort level.

    HS: no pain (score 0) → worst pain imaginable (score 10)

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

Clinical Evaluation of Treatment With Micro-surgical Management of Type I Multiple Gingival Recessions Using Coronally Advanced Flap With Either Advanced Platelet-Rich Fibrin or Concentrated Growth Factor: A Comparative Analysis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2022
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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