Growth Factors, Combined Defect ofNCT05319938
Growth Factors in the Treatment of the Multiple Gingival Recessions
A study testing CAF only, CAF+CGF and CAF+A-PRF in people with Growth Factors, Combined Defect of and Gingival Recession, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Factors, Combined Defect of, Gingival Recession
- What is being tested?
- CAF only, CAF+CGF and CAF+A-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 1 Dec 2020
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
- Being tested
- CAF only, CAF+CGF, CAF+A-PRF
- Medical subject headings
- Growth Factors, Combined Defect of, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF onlyProcedure or surgery
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+CGFProcedure or surgery
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-PRFProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CAF only | Active comparator | Only Coronally Advanced Flap technique Receives: Procedure: CAF only |
| CAF+CGF | Experimental | Concentrated Growth Factor (CGF) applied together with Coronally Advanced Flap (CAF) technique Receives: Procedure: CAF+CGF |
| CAF+A-PRF | Experimental | Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique Receives: Procedure: CAF+A-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 6 months of the percent of complete and mean root coverage
Secondary outcomes (5)
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.
Measured: Change from baseline at 6 months of the gingival thickness
Keratinized gingiva width (WKG)
The WKG was determined by subtracting the VGR from the CEJ- MGJ (mucogingival junction).
Measured: Change from baseline at 6 months of keratinized gingiva width
Patient esthetic score (PES)
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)
Measured: Change from baseline at 6 months of the patient esthetic score
Patient comfort score (PCS)
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).
Measured: Change from baseline at 6 months of the patient comfort score
Hypersensitivity score (HS)
"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)
Measured: Change from baseline at 6 months of the hypersensitivity score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Dec 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Factors, Combined Defect ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Öngöz Dede, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319938
- Sponsor's protocol ID
- HD-1726
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05319938
- Acronym / sponsor ID
- HD-1726
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAF only | Active comparator | Procedure: CAF onlyOnly Coronally Advanced Flap technique |
| CAF+CGF | Experimental | Procedure: CAF+CGFConcentrated Growth Factor (CGF) applied together with Coronally Advanced Flap (CAF) technique |
| CAF+A-PRF | Experimental | Procedure: CAF+A-PRFAdvanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 %
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAF onlyAfter 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. | Procedure or surgery | CAF only |
| CAF+CGFAfter 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. | Procedure or surgery | CAF+CGF |
| CAF+A-PRFAfter 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. | Procedure or surgery | CAF+A-PRF |
Primary outcome
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.
5 secondary outcomes
Gingival thickness
Time frame: Change from baseline at 6 months of the gingival thickness
Keratinized gingiva width (WKG)
Time frame: Change from baseline at 6 months of keratinized gingiva width
Patient esthetic score (PES)
Time frame: Change from baseline at 6 months of the patient esthetic score
Patient comfort score (PCS)
Time frame: Change from baseline at 6 months of the patient comfort score
Hypersensitivity score (HS)
Time frame: Change from baseline at 6 months of the hypersensitivity score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF only, CAF+CGF and CAF+A-PRF in people with Growth Factors, Combined Defect of and Gingival Recession, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 8 inclusion and 5 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 and mean root coverage (time frame: Change from baseline at 6 months of the percent of complete and mean root coverage). 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 Apr 2022.