Post Operative Pain Clinical Trial
Official title:
Impact of Advanced Platelet Rich Fibrin and Enamel Matrix Derivative on Clinical and Molecular Wound Healing Parameters After Surgical Removal of Mandibular Third Molars
Verified date | January 2024 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Brief summary The goal of this study is to compare the effects of advanced platelet rich fibrin and enamel matrix derivative placed in the extraction alveoli of patients who had surgical removal of mandibular wisdom teeth. The questions it aims to answer/evaluate are: - postoperative pain, swelling, trismus, early wound healing using soft tissue healing index - level of early local inflammatory response by measuring levels of inflammatory mediators in wound exudate - degree of wound healing by measuring levels of early wound healing mediators in wound exudate - incidence of alveolar osteitis and delayed infection - levels of probing depth, clinical attachment loss, gingival margin level, bleeding on probing, gingival index, plaque index of the second mandibular molar 3 months after surgery Participants of the study will be asked: - for their preoperative clinical measurements (swelling, trismus, periodontal parameters) to be taken by the principal investigator - to provide 20 ml of venous blood if necessary - to preoperatively provide gingival crevicular fluid in the region of distal surface of the second mandibular molar and postoperatively wound exudate - to note the number of painkiller pills taken after surgery and pain levels in different time points - to come to regular checkups in which clinical measuring of postoperative swelling, trismus levels and periodontal parameters will be performed
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | March 20, 2024 |
Est. primary completion date | January 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Systemically healthy individuals (ASA I by American Society of Anesthesiologists classification); - Age 18-30 years; - Patients who have bilaterally impacted mandibular wisdom teeth which are in contact with the distal surface of the second mandibular molar. Exclusion Criteria: - Systemic disorders; - Patients who have difficulties when phlebotomy is performed - History of pericoronitis in the area of impacted mandibular wisdom tooth - History of NSAIDs, corticosteroids and antibiotics intake within 10 days before surgery |
Country | Name | City | State |
---|---|---|---|
Serbia | School of dental medicine, University of Belgrade | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
Gupta N, Agarwal S. Advanced-PRF: Clinical evaluation in impacted mandibular third molar sockets. J Stomatol Oral Maxillofac Surg. 2021 Feb;122(1):43-49. doi: 10.1016/j.jormas.2020.04.008. Epub 2020 Apr 29. — View Citation
Nasirzade J, Kargarpour Z, Hasannia S, Strauss FJ, Gruber R. Platelet-rich fibrin elicits an anti-inflammatory response in macrophages in vitro. J Periodontol. 2020 Feb;91(2):244-252. doi: 10.1002/JPER.19-0216. Epub 2019 Sep 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | 24 hours after surgery | |
Primary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | 24-48 hours after surgery | |
Primary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | 48-72 hours after surgery | |
Primary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | 72 hours- 7 days after surgery | |
Primary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | 24 hours after surgery | |
Primary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | 24-48 hours after surgery | |
Primary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | 48-72 hours after surgery | |
Primary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | 72 hours- 7 days after surgery | |
Primary | Evaluation of postoperative pain by marking the number of pain tablets and time of their consumption | After measuring their pain level on VAS and VRS, patients will be writing the number of Paracetamol tablets (500mg) that were taken and exact time of their consumption. | 24 hours after surgery | |
Primary | Evaluation of postoperative pain by marking the number of pain tablets and time of their consumption | After measuring their pain level on VAS and VRS, patients will be writing the number of Paracetamol tablets (500mg) that were taken and exact time of their consumption. | 24-48 hours after surgery | |
Primary | Evaluation of postoperative pain by marking the number of pain tablets and time of their consumption | After measuring their pain level on VAS and VRS, patients will be writing the number of Paracetamol tablets (500mg) that were taken and exact time of their consumption. | 48-72 hours after surgery | |
Primary | Evaluation of postoperative pain by marking the number of pain tablets and time of their consumption | After measuring their pain level on VAS and VRS, patients will be writing the number of Paracetamol tablets (500mg) that were taken and exact time of their consumption. | 72 hours- 7 days after surgery | |
Primary | Evaluation of preoperative tragus- oral commissure and outer eye canthus-angle of the mandible distances at the side of the extraction | Postoperative swelling will be evaluated by measuring distances tragus- oral commissure and outer eye canthus-angle of the mandible at the side of the extraction by using soft tape, expressed in millimeters. | 1 hour preoperatively | |
Primary | Evaluation of postoperative swelling | Postoperative swelling will be evaluated by measuring distances tragus- oral commissure and outer eye canthus-angle of the mandible at the side of the extraction by using soft tape, expressed in millimeters. | 24 hours after surgery | |
Primary | Evaluation of postoperative swelling | Postoperative swelling will be evaluated by measuring distances tragus- oral commissure and outer eye canthus-angle of the mandible at the side of the extraction by using soft tape, expressed in millimeters. | 48 hours after surgery | |
Primary | Evaluation of postoperative swelling | Postoperative swelling will be evaluated by measuring distances tragus- oral commissure and outer eye canthus-angle of the mandible at the side of the extraction by using soft tape, expressed in millimeters. | 72 hours after surgery | |
Primary | Evaluation of postoperative swelling | Postoperative swelling will be evaluated by measuring distances tragus- oral commissure and outer eye canthus-angle of the mandible at the side of the extraction by using soft tape, expressed in millimeters. | 7 days after surgery | |
Primary | Evaluation of preoperative maximal inter-incisor distance | Maximal inter-incisor distance at baseline will be measured by means of a soft tape, and expressed in millimeters (mm). | 1 hour preoperatively | |
Primary | Evaluation of postoperative trismus | Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). | 24 hours postoperatively | |
Primary | Evaluation of postoperative trismus | Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). | 48 hours postoperatively | |
Primary | Evaluation of postoperative trismus | Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). | 7 days postoperatively | |
Primary | Relative gene expression of inflammatory and wound healing mediators in gingival crevicular fluid of the distal sulcus of the second mandibular molar preoperatively | To measure the relative gene expression of VEGF, TGF-ß1, IL-6, IL-1ß in samples of gingival crevicular fluid before surgical removal of impacted mandibular wisdom teeth. | 1 hour preoperatively | |
Primary | Protein expression of specialized pro-resolving inflammation mediator maresin 1 (Mar1) in gingival crevicular fluid of the distal sulcus of the second mandibular molar preoperatively | To measure the protein expression of Mar1 in samples of gingival crevicular fluid before surgical removal of impacted mandibular wisdom teeth | 1 hour preoperatively | |
Primary | Relative gene expression of inflammatory and wound healing mediators in wound exudate after surgical removal of impacted mandibular wisdom teeth | To measure the relative gene expression of VEGF, TGF-ß1, IL-6, IL-1ß in samples of wound exudate after surgical removal of impacted mandibular wisdom teeth. | 48 hours postoperatively | |
Primary | Relative gene expression of inflammatory and wound healing mediators in wound exudate after surgical removal of impacted mandibular wisdom teeth | To measure the relative gene expression of VEGF, TGF-ß1, IL-6, IL-1ß in samples of wound exudate after surgical removal of impacted mandibular wisdom teeth. | 7 days postoperatively | |
Primary | Protein expression of specialized pro-resolving inflammation mediator maresin 1 (Mar1) in wound exudate after surgical removal of impacted mandibular wisdom teeth | To measure the protein expression of Mar1 in samples of wound exudate after surgical removal of impacted mandibular wisdom teeth | 48 hours postoperatively | |
Primary | Protein expression of specialized pro-resolving inflammation mediator maresin 1 (Mar1) in wound exudate after surgical removal of impacted mandibular wisdom teeth | To measure the protein expression of Mar1 in samples of wound exudate after surgical removal of impacted mandibular wisdom teeth. | 7 days postoperatively | |
Primary | Evaluation of soft tissue healing using Landry healing index | Independent researcher will evaluate soft tissue healing by marking the number in front of the given description: 1. Very poor- tissue color: more than 50% of gingivae red Response to palpation: bleeding Granulation tissue: present Incision margin: not epithelialised, with loss of epithelium beyond margins Suppuration: present; 2. Poor- Tissue color: more than 50% of gingivae red Response to palpation: bleeding Granulation tissue: present Incision margin: not epitheliased with connective tissue exposed. 3. Good- Tissue color: less than 50% of gingivae red Response to palpation: no bleeding Granulation tissue: none Incision margin: no connective tissue exposed 4. Very good- Tissue color: less than 25% of gingivae red Response to palpation: no bleeding Granulation tissue: none Incision margin: no connective tissue exposed 5. Excellent-Tissue color: all gingivae pink Response to palpation:no bleeding Granulation tissue:none; Incision margin:no connective tissue exposed | 7 days after surgery | |
Secondary | Evaluation of preoperative probing depth of mandibular second molar in six points | Probing depth is the distance from the base of the sulcus/pocket to the gingival margin and it will be measured in three following buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface of second molar, lingual distal point and mid lingual point on the lingual surface using periodontal probe calibrated in millimeters. The measurements will be expressed in millimeters. | 1 hour preoperatively | |
Secondary | Evaluation of postoperative probing depth of mandibular second molar in six points | Probing depth is the distance from the base of the sulcus/pocket to the gingival margin and it will be measured in three following buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface of second molar, lingual distal point and mid lingual point on the lingual surface using periodontal probe calibrated in millimeters. The measurements will be expressed in millimeters. | 3 months after surgery | |
Secondary | Evaluation of preoperative gingival margin level of mandibular second molar in six points | Gingival margin level is the distance from gingival margin to the cementoenamel junction and it will be measured in three following buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface of second molar, lingual distal point and mid lingual point on the lingual surface using periodontal probe calibrated in millimeters. The measurements will be expressed in millimeters. | 1 hour preoperatively | |
Secondary | Evaluation of postoperative gingival margin level of mandibular second molar in six points | Gingival margin level is the distance from gingival margin to the cementoenamel junction and it will be measured in three following buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface of second molar, lingual distal point and mid lingual point on the lingual surface using periodontal probe calibrated in millimeters. The measurements will be expressed in millimeters. | 3 month after surgery | |
Secondary | Evaluation of preoperative clinical attachment level of mandibular second molar in six points | Clinical attachment level of mandibular second molar will be evaluated through a formula by subtracting gingival margin level measurement from probing depth measurement in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface of second molar, lingual distal point and mid lingual point on the lingual surface. The measurements will be expressed in millimeters. | 1 hour preoperatively | |
Secondary | Evaluation of postoperative clinical attachment level of mandibular second molar in six points | Clinical attachment level of mandibular second molar will be evaluated through a formula by subtracting gingival margin level measurement from probing depth measurement in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface of second molar, lingual distal point and mid lingual point on the lingual surface. The measurements will be expressed in millimeters. | 3 months after surgery | |
Secondary | Evaluation of preoperative bleeding on probing of mandibular second molar in six points | Gentle periodontal probing will be performed in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface, lingual distal point and mid lingual point on the lingual surface. Occurrence of bleeding on gentle probing will be marked as 1, no bleeding will be marked as 0. | 1 hour preoperatively | |
Secondary | Evaluation of postoperative bleeding on probing of mandibular second molar in six points | Gentle periodontal probing will be performed in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface, lingual distal point and mid lingual point on the lingual surface. Occurrence of bleeding on gentle probing will be marked as 1, no bleeding will be marked as 0. | 3 months after surgery | |
Secondary | Evaluation of preoperative plaque index score of mandibular second molar | Gentle periodontal probing will be performed in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface. Each point will be given one of the following scores: 0- no plaque; 1-thin plaque layer at the gingival margin, only detectable by probing; 2-moderate plaque layer at the gingival margin, plaque visible to the naked eye; 3-abundant plaque along the gingival margin, interdental spaces filled with plaque.
The score will be expressed in the mean value of acquired measurements. |
1 hour preoperatively | |
Secondary | Evaluation of postoperative plaque index score of mandibular second molar | Gentle periodontal probing will be performed in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface. Each point will be given one of the following scores: 0- no plaque; 1-thin plaque layer at the gingival margin, only detectable by probing; 2-moderate plaque layer at the gingival margin, plaque visible to the naked eye; 3-abundant plaque along the gingival margin, interdental spaces filled with plaque.
The score will be expressed in the mean value of acquired measurements. |
3 months postoperatively | |
Secondary | Evaluation of preoperative gingival index score of mandibular second molar | Gentle periodontal probing will be performed in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface. Each point will be given one of the following scores: 0-normal gingiva; 1- mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 -moderate inflammation: redness, edema, and glazing or bleeding on probing; 3- severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration.
The score will be expressed in the mean value of acquired measurements. |
1 hour preoperatively | |
Secondary | Evaluation of postoperative gingival index score of mandibular second molar | Gentle periodontal probing will be performed in three buccal points, mesial, mid buccal, distal and in medial distal point on the distal surface. Each point will be given one of the following scores: 0-normal gingiva; 1- mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 -moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3- severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration.
The score will be expressed in the mean value of acquired measurements. |
3 months after surgery | |
Secondary | Incidence of postoperative alveolar osteitis | Occurrence of postoperative complication such as alveolar osteitis will be monitored within first 7 days after surgery and recorded. | Within 7 days after surgery | |
Secondary | Incidence of postoperative infection | Occurrence of postoperative complication such as postoperative infection will be monitored within first three months after surgery and recorded. | Within 3 months after surgery |
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