Wound Heal Clinical Trial
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
NCT number | NCT04805463 |
Other study ID # | 2019/216 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | May 30, 2020 |
Verified date | March 2021 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | May 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Department of Periodontology, Faculty of Dentistry, Inonu University | Malatya | Battalgazi |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
Turkey,
Crichton N. Visual analogue scale (VAS). J Clin Nurs. 2001;10(5):706-6
Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. Epub 2006 Jan 10. — View Citation
Landry RG. Effectiveness of Benzydamine HC1 in the Treatment of Periodontal Post-surgical Patients: Faculty of Dentistry, University of Toronto; 1985.
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. — View Citation
Miller CS, Damm DD. Incidence of verapamil-induced gingival hyperplasia in a dental population. J Periodontol. 1992 May;63(5):453-6. — View Citation
Miranda J, Brunet L, Roset P, Berini L, Farré M, Mendieta C. Prevalence and risk of gingival enlargement in patients treated with nifedipine. J Periodontol. 2001 May;72(5):605-11. — View Citation
Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scarì 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. — View 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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | |
Primary | 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. | The change in wound surface epithelization was evaluated on the 7th, 14th and 28th days postoperatively. | |
Primary | 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. | Wound healing evaluation with LTH index was performed at the postoperative 7th, 14th and 28th day controls. | |
Primary | 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. | Evaluation of VAS-Pain change on postoperative 7th, 14th and 28th days. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05023135 -
DeepView SnapShot Portable (DV-SSP): Device Training Study
|
||
Recruiting |
NCT03459547 -
Soft Peri-implant Tissue Around Different Abutment Materials
|
N/A | |
Recruiting |
NCT05608187 -
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
Active, not recruiting |
NCT03649308 -
Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
|
N/A | |
Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
Completed |
NCT03285542 -
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05474911 -
PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
|
N/A | |
Recruiting |
NCT05689775 -
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
|
||
Recruiting |
NCT04849143 -
The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
|
N/A | |
Completed |
NCT03596112 -
The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care
|
N/A | |
Recruiting |
NCT05169814 -
Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds
|
Early Phase 1 | |
Completed |
NCT04545476 -
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
|
N/A | |
Completed |
NCT06020157 -
Comparison of Simple and Continuous Suture Techniques in Oral Surgery
|
N/A | |
Recruiting |
NCT05133570 -
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
|
||
Recruiting |
NCT04901325 -
Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)
|
Phase 2 | |
Withdrawn |
NCT03668665 -
Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"
|
Phase 3 | |
Completed |
NCT03703479 -
Effect of A-PRF After Removal of Wisdom Teeth
|
N/A | |
Recruiting |
NCT03204851 -
Microlyte Dressing in the Management of Wounds
|
N/A | |
Recruiting |
NCT06117436 -
Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients
|
Phase 2/Phase 3 | |
Completed |
NCT05618912 -
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
|
N/A |