Gingival Recession Clinical Trial
Official title:
Comparison of the Effects of Different Platelet Concentrates on Palatal Wound Healing
NCT number | NCT04097509 |
Other study ID # | 2018/46 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | June 10, 2019 |
Verified date | September 2019 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 10, 2019 |
Est. primary completion date | February 10, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 53 Years |
Eligibility |
Inclusion Criteria: - • Patients older than age 18 - Patients with good oral hygiene - Patients who do not use drugs that affect wound healing - Patients who are systemically healthy - Patients who are non-smokers - Patients who do not have coagulation disorder - Patients who do not have nausea - Patients who are not anti-inflammatory drug allergy sufferers Exclusion Criteria: - • Patients who have systematic disorders such as (diabetes, hypertension, radiotherapy, chemotherapy, etc.) - Patients who use any medication that may affect wound healing - Patients with coagulation disorders - Patients who are smokers and alcohol users - Patients who are pregnant and breastfeeding - Patients with poor oral hygiene - Patients who have nausea - Patients who are anti-inflammatory drug allergy sufferers - Patients who do not attend regular check-ups |
Country | Name | City | State |
---|---|---|---|
Turkey | Inonu University, Faculty of Dentistry, Department of Periodontics, | Malatya |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Epithelialization of wound in % at different time points | Completion of wound epithelialization was evaluated clinically using H2O2 foaming test. After the wound area was dried with gauze, 3% of hydrogen peroxide (H2O2) was applied to the wound with an injector. The result of H2O2 application was evaluated as bubbling within / without palate. The absence of foaming indicates that epithelialization is complete | Epithelialization was evaluated on the 3rd, 7th, 14th day and 1st month. | |
Primary | Change of color, contour and distortion of wound in the total score of scale in numerical at different time points | The Modified Manchester Scar (MMS) Scale was used to assess the color, contour, and distortion of the wound . The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared to the neighboring mucosa. The contour of the wound was evaluated as similar (score 0), slightly raised or indented (score 1) and hypertrophic (score 2) when compared to surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1) and obvious distortion (score 2) . The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair. | MMS was evaluated on the 3rd, 7th, 14th day and 1st month. | |
Primary | Change of redness, presence of bleeding, granulation tissue, epithelialization and suppuration in % at different time points | Wound healing was evaluated using the Landry, Turnbull, Howley (LTH) index, which classifies the healing process according to redness, presence of bleeding, granulation tissue, epithelialization and suppuration. Improvement in this index was scored between 1 (very poor recovery) and 5 (excellent recovery).The sum of the scores shows the repair score of the wound. Evaluation of wound healing process with LTH index was performed on the 3rd, 7th and 14th days and on the 1st and 3rd month controls. | LTH was evaluated on the 3rd, 7th, 14th day and 1st month. | |
Secondary | change of Postoperative Pain Evaluation (VAS) in total score of scale in numerical at different time points | VAS was used for postoperative pain evaluation. On the two ends of a 100 mm line, the definition of 'no pain 'and 'the most severe pain of my life' was written and the patient was asked to mark the appropriate position on this line. The distance from the no pain 'end to the patient's mark was measured in millimeters to determine the patient's pain. Pain assessment was performed on the 3rd, 7th, 14th and 1st month. | VAS was evaluated on the 3rd, 7th, 14th day and 1st month. |
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