Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.
Primary Purpose
Wound Heal, Gingival Overgrowth, Gingival Enlargement
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control group
PRF group
CGF group
AFG group
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Heal focused on measuring Autologous fibrin glue, Concentrated growth factor, Gingivectomy, Gingivoplasty, Platelet rich fibrin
Eligibility Criteria
Inclusion Criteria:
- Patients who are systemically healthy, have chronic inflammatory gingival enlargement in the maxillary and mandibular anterior region, and who do not have attachments and bone loss in clinical and radiographic evaluation.
Exclusion Criteria:
- Patients with a history of periodontal treatment in the last 6 months, smokers, those using drugs that may cause gingival enlargement, and pregnant or breastfeeding women were excluded.
Sites / Locations
- Department of Periodontology, Faculty of Dentistry, Inonu University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
control group
PRF group
CGF group
AFG group
Arm Description
After gingivectomy and released into the secondary wound healing gingivoplasty group.
The group in which PRF was applied to the wound surface after gingivectomy and gingivoplasty.
The group in which CGF was applied to the wound surface after gingivectomy and gingivoplasty.
The group in which AFG was applied to the wound surface after gingivectomy and gingivoplasty.
Outcomes
Primary Outcome Measures
Determination of non-epithelialized areas on the wound surface
Mira-2 tone solution was used to identify non-epithelialized areas on wound surfaces after gingivectomy and gingivoplasty. Mira-2 tone was applied to the wound surfaces and dark dyed areas were calculated as mm2 in Image j program.
Epithelialization test
H2O2 was used to identify non-epithelialized areas. If bubbling is observed after the application of H202 to the wound surface, epithelialization was incomplete, if bubbling was not observed, epithelialization was recorded as completed.
Healing index
Landry, Turnbull, Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration, was evaluated.
Postoperative pain
VAS was used for postoperative pain assessment. The patients were asked to evaluate the level of pain from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale during the control sessions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04805463
Brief Title
Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.
Official Title
Evaluation of the Effects of PRF, CGF and AFG Application on Wound Healing Following Gingivectomy and Gingivoplasty Operations: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. The postoperative PRF, CGF, and AFG applied areas were compared with the control regions. 0th,7 th,14 th and 28 th on the days, the surgical area was painted with mira-2-tone solution and evaluated in the ImageJ program. Measurements of clinical periodontal parameters including PI, GI, SC and SD were recorded at the beginning, after IPT and 28 days after the operation. Wound healing was evaluated with H2O2 test, VAS-Pain, and LTH index on 7th, 14th and 28th days. The patients were asked to evaluate their aesthetic perceptions on the VAS aesthetic scale.
Detailed Description
Study design and patient selection
In this randomized, controlled, split-mouth (lower, upper jaw, right and left anterior regions) clinical study, who applied to ฤฐnรถnรผ University Faculty of Dentistry Department of Periodontology between January 2020 and May 2020, due to gingival problems, chronic examination was performed. included individuals diagnosed with inflammatory gingival enlargement.
All patients received initial periodontal therapy (BPT). The patients were called for control after 2 weeks and surgery was planned for the patients who provided adequate oral hygiene. In our study, the vertical DM index, first described by Goaz and Angelopoulos, and later modified by Damm and Miller (DM), was used to classify the gingival enlargement in the vertical direction (1). In order to classify the bucco-lingual gingival growths in the interdental papillae, the horizontal MB index, first described by Seymour et al. And later modified by Miranda and Brunet (MB), was used (2). As a result of the measurements made, grades other than score 0 according to the DB and MB indices were accepted as having gingival enlargement. The distribution of control (n = 19) and three test groups (n = 19, n = 19, n = 19) after gingivectomy and gingivoplasty was randomized (block randomization).
Clinical Measurements
In clinical periodontal evaluation, plaque index (PI) (3), gingival index (GI) (4), bleeding on probing (SC) and probing depth (SD ) measurements were performed at baseline (T0), after BPT (T1) and on the 28th day (T2) after gingivectomy and gingivoplasty operation. Measurements were made in a total of 6 regions of all teeth: mesio-buccal, mid-buccal, disto-buccal, disto-lingual / palatinal, mid-lingual / palatinal and mesio-lingual / palatinal. Clinical periodontal measurements of all teeth of the individuals included in the study were performed by a single investigator (E.B.).
Gingivectomy and gingivoplasty
Before surgery, all patients were gargled with 0.12% chlorhexidine for 1 minute. The incision lines were determined by applying infiltrative anesthesia (Maxicaine Fort) to the areas to be operated, and the external bevel incision was performed with a # 15 scalpel (Brocheยฎ Medical scalpel tip; carbon steel) and a Kirkland blade (Hu-Friedy, Chicago, IL, USA). Orban blade (Hu-Friedy, Chicago, IL, USA) was used in the interproximal areas. After the incision was completed, the remaining gum pieces were removed with the help of periodontal curette and microsurgical scissors (Hu-Friedy, Chicago, IL, USA). Then gingivoplasty was performed. After gingivectomy and gingivoplasty, the control areas were left to recover spontaneously. PRF, CGF and AFG were applied to the test areas. Surgical areas in control and test areas were covered with a periodontal pat (Coe-Pak, lsip, IL, USA).
Preparation of platelet-rich fibrin membrane
Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. The collected venous blood was placed in the PC-02 (Process, Nice, France) centrifuge device and centrifuged at 3000 rpm for 10 (400xg) minutes (5). The obtained PRF was taken out of the tube, placed in the PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. The prepared PRF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.
Preparation of concentrated growth factor membrane
Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. These tubes were then centrifuged in a centrifuge device (Medifuge; Silfradent srl, Sofia, Italy) using a program with the following features: acceleration for 30 seconds followed by 2 minutes (692xg) at 2700 rpm, 4 minutes (547xg) at 2400 rpm, 2700 rpm. Centrifugation for 4 minutes (592xg) at 3000 rpm for 3 minutes (855xg) and finally deceleration for 36 seconds (6). After centrifugation, CGF was taken from the middle part of the tube, placed in PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. Prepared CGF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.
Preparation of autologous fibrin glue
Venous blood taken from the patient was transferred to a 9 ml glass-covered plastic tube (Vacuette serum tubes, Greiner Bio-one) that did not contain any anticoagulants. Sohn et al. In the protocol he recommended (7), the venous blood collected in the tube was centrifuged in a centrifuge device (Medifuge, Silfradent, Italy) at 2700 rpm (approximately 692 g) for 2 min. AFG obtained from the upper part of the tube after centrifugation was collected with the help of an injector and transferred to the metal body. The polymerization was allowed for 15-20 minutes. After polymerization was completed, AFG was applied to the surgical operation area and the operation area was covered with a periodontal pat.
Post Operative Care and Suggestion
Patients were advised to protect the wound area with periodontal pats from trauma, not to consume too hot and too cold foods, and to eat soft foods. It was stated that the pat should be kept in the mouth for 1 week, and if the pat was damaged during this period, they should apply to our clinic immediately. Patients were prescribed paracetamol-containing analgesic (Parol 500 mg) and a mouthwash containing 0.12% chlorhexidine to use three times a day for a week. The patients were only advised not to brush their teeth in the operation area for 1 week. It was stated that he should provide oral hygiene in areas that were not operated. They were advised to use an extra soft toothbrush in the area after the pat was removed.
Surface area determination
Mira-2-tone, a plaque staining agent (GMBH & Co., Duisburg, Germany), was used to detect wound surface epithelization at baseline, postoperative 7, 14, and 28 days. Standardized photographs were taken from each patient to evaluate the dark stained areas after staining with Mira-2-tone in the gingiva where epithelialization was not completed and wound healing continued. During the photo shoot, the patients were seated upright and facing straight ahead. All photos were taken by a single person on the same camera (Nikon Coolpix 4500, Tokyo, Japan), at the same distance (20 cm) and light values (ISO-800). The photo size was scaled by using a 10 mm Williams periodontal probe during the photo taking. Wound surface epithelization was calculated using Image J software program (National Institutes of Health, USA ImageJ 1.48V) from the photographs obtained. Each measurement step was done by the same researcher (E.B.) each time. The calibration of the person who made the measurements was performed by repeating the wound surface epithelialization area measurement at one-week intervals on the photo images of 10 patients who had undergone gingivectomy and gingivoplasty surgery and were not included in the study. In these two separate evaluations, the calculations were 95% compatible.
Epithelialization test
In order to evaluate the wound surface epithelization during the healing process, 3% H2O2 was applied to the surface of the operation area with the help of an injector. As a result of the decomposition of H2O2 into water and oxygen through the catalase enzyme released by the blood cells present in the wound area, it was evaluated as "epithelization incomplete" if foaming was observed with oxygen formation, and "epithelization completed" if foaming was not observed . H2O2 test was performed at the controls on the 7th, 14th and 28th days after the operation.
Healing index Landry, Turnbull, and Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration (8). The wound healing process with LTH index was performed at the postoperative 7th, 14th and 28th days.
Postoperative pain and aesthetic
VAS was used for postoperative pain and aesthetic evaluation (9). The patient's 7th, 14th He was asked to evaluate the level of pain he felt from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale in the control sessions on the 28th and 28th days. In the control session on the 28th day, the patients were asked to evaluate their aesthetic perceptions from 1 to 10 according to the VAS-Aesthetics (1: dissatisfied, 10: very satisfied) scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Gingival Overgrowth, Gingival Enlargement, Platelet Rich Fibrin
Keywords
Autologous fibrin glue, Concentrated growth factor, Gingivectomy, Gingivoplasty, Platelet rich fibrin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth design was used in the study. The chin was divided into lower, upper and right, and left anterior regions. The distribution of the platelet concentrate and control group to be used after gingivectomy and gingivoplasty was randomly decided.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Experimental
Arm Description
After gingivectomy and released into the secondary wound healing gingivoplasty group.
Arm Title
PRF group
Arm Type
Experimental
Arm Description
The group in which PRF was applied to the wound surface after gingivectomy and gingivoplasty.
Arm Title
CGF group
Arm Type
Experimental
Arm Description
The group in which CGF was applied to the wound surface after gingivectomy and gingivoplasty.
Arm Title
AFG group
Arm Type
Experimental
Arm Description
The group in which AFG was applied to the wound surface after gingivectomy and gingivoplasty.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area.
Intervention Type
Other
Intervention Name(s)
PRF group
Intervention Description
The group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF.
Intervention Type
Other
Intervention Name(s)
CGF group
Intervention Description
The group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF.
Intervention Type
Other
Intervention Name(s)
AFG group
Intervention Description
The group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG.
Primary Outcome Measure Information:
Title
Determination of non-epithelialized areas on the wound surface
Description
Mira-2 tone solution was used to identify non-epithelialized areas on wound surfaces after gingivectomy and gingivoplasty. Mira-2 tone was applied to the wound surfaces and dark dyed areas were calculated as mm2 in Image j program.
Time Frame
Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.
Title
Epithelialization test
Description
H2O2 was used to identify non-epithelialized areas. If bubbling is observed after the application of H202 to the wound surface, epithelialization was incomplete, if bubbling was not observed, epithelialization was recorded as completed.
Time Frame
The change in wound surface epithelization was evaluated on the 7th, 14th and 28th days postoperatively.
Title
Healing index
Description
Landry, Turnbull, Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration, was evaluated.
Time Frame
Wound healing evaluation with LTH index was performed at the postoperative 7th, 14th and 28th day controls.
Title
Postoperative pain
Description
VAS was used for postoperative pain assessment. The patients were asked to evaluate the level of pain from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale during the control sessions.
Time Frame
Evaluation of VAS-Pain change on postoperative 7th, 14th and 28th days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are systemically healthy, have chronic inflammatory gingival enlargement in the maxillary and mandibular anterior region, and who do not have attachments and bone loss in clinical and radiographic evaluation.
Exclusion Criteria:
Patients with a history of periodontal treatment in the last 6 months, smokers, those using drugs that may cause gingival enlargement, and pregnant or breastfeeding women were excluded.
Facility Information:
Facility Name
Department of Periodontology, Faculty of Dentistry, Inonu University
City
Malatya
State/Province
Battalgazi
ZIP/Postal Code
44280
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have other studies using this data.
Citations:
PubMed Identifier
11394395
Citation
Miranda J, Brunet L, Roset P, Berini L, Farre M, Mendieta C. Prevalence and risk of gingival enlargement in patients treated with nifedipine. J Periodontol. 2001 May;72(5):605-11. doi: 10.1902/jop.2001.72.5.605.
Results Reference
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PubMed Identifier
14158464
Citation
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
Results Reference
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PubMed Identifier
14121956
Citation
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
Results Reference
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PubMed Identifier
16504850
Citation
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Results Reference
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Citation
Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scari G, Sacco L, Batani T, Rezzani R. Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction. Microsc Res Tech. 2011 Aug;74(8):772-7. doi: 10.1002/jemt.20968.
Results Reference
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Sohn D-S, Huang B, Kim J, Park WE, Park CC. Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix (Sticky bone) and CGF-enriched fibrin membrane in Implant Dentistry. J Implant Adv Clin Dent. 2015;7:11-29.
Results Reference
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Results Reference
result
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Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.
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