Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: A Randomized, Controlled, Examiner-Blinded Clinical Trial Using CAD/CAM
The International journal of periodontics & restorative dentistry. 2020;40(2):e73-e83
This study aimed to create papilla with concentrated growth factor (CGF) in cases in which the interdental papilla was not able to fill the interproximal space (IPS) due to physiologic factors. A three-dimensional digital model of this space with the digital impression obtained from direct intraoral scanning of IPS was created. This study aimed to evaluate the efficacy of CGF in the regeneration of multiple adjacent papillary losses (MAPL), with the change in the IPS area calculated on intraorally scanned images obtained with digital impressions. This study included 160 teeth from 40 patients with 120 papillary losses. Patients were randomly allocated to the test group (TG) (n = 20), with 60 MAPL (three adjacent, lost interdental papillae per patient) receiving minimally invasive surgery with CGF, or the control group (CG) (n = 20), with 60 MAPL without surgery. A total of 480 images were uploaded to a software. The patients' age, gender, Plaque Index, bleeding on probing, and mean probing pocket depth values were evaluated. Papillary area (PA) were calculated between the two central, lateral-central, and lateral-canine teeth at baseline and posttreatment periods of 3, 6, and 12 months in both groups. Papillary filling percentage, keratinized-gingiva width, papillary thickness, thrombocyte, count and mean platelet volume were recorded in TG. Considering the variables in TG and CG, there was no difference in terms of age, gender, and periodontal parameters (P > .05). PA at 3, 6, and 12 months showed statistically significant differences from baseline values in TG (P < .001) but not in CG (P > .05). In TG, a moderate positive correlation was found between the midline papillary thickness and the 3-, 6-, and 12-month filling percentages (r: 0.506, P = .023; r: 0.509, P = .022; and r: 0.515, P = .02, respectively), and a high positive correlation was determined between thrombocyte count and the 6- and 12-month filling percentages (r: 0.733, P < .001; and r: 0.744, P < .001, respectively). CGF provided papillary regeneration in the treatment of MAPL and supported three-dimensional structure of the regenerated interdental papilla throughout 1 year.
Albumin-Impregnated Allograft Filling of Surgical Extraction Sockets Achieves Better Bone Remodeling Than Filling with Either Blood Clot or Bovine Xenograft
The International journal of oral & maxillofacial implants. 2020;35(2):297-304
PURPOSE The goal of this study was to compare bone graft materials in mandibular third molar extraction sockets and to monitor bone remodeling and complications. MATERIALS AND METHODS Patients with bilateral, impacted mandibular third molars were involved. Twenty-four patients were planned to be randomly assigned to three possible treatments: (1) the control sockets were left empty; (2) the socket was filled with bovine xenograft (Bio-Oss); or (3) the socket was filled with albumin-impregnated bone allograft (BoneAlbumin). Postoperative pain during the first week was determined with the visual analog scale. Cone beam computed tomography (CBCT) images were taken at 6 and 12 weeks and 1 year postoperatively for micromorphologic analysis and measurement of pocket depth at the second molar. Patients and image analyses were blinded toward the treatment group (randomized double-blind split-mouth design). RESULTS Postoperative pain was lowest in the allograft group (control: 5.06 +/- 0.53; xenograft: 5.85 +/- 0.42; allograft: 3.94 +/- 0.52; P < .05). At weeks 6 and 12, early signs of remodeling were observed in the allograft group and the controls, while bone xenograft was still demarcated from the host bone. The 1-year CBCT images showed complete remodeling and integration of allograft with natural trabecular structure, while the xenograft particles were still visible. Support for the second molar was significantly better, as evidenced by less deep and prevalent pockets in the allograft-filled group compared with the controls (P = .017). CONCLUSION Filling an extraction socket with albumin-integrated allografts provides superior bone regeneration compared to either native bone buildup or xenograft application or socket regeneration without bone grafting.
Randomized Clinical Trial Comparing Three Local Hemostatic Agents for Dental Extractions in Patients under Chronic Anticoagulant Therapy - A Comparative Study
Annals of maxillofacial surgery. 2020;10(2):292-296
INTRODUCTION Oral anticoagulants are widely used worldwide for many systemic diseases. Recent oral surgical protocols suggest that therapeutic levels of the anticoagulant drug should be maintained for simple dental extractions because bleeding complications could be managed with proper local hemostasis. The aim of the present study was to compare bleeding complication of three different local hemostatic agents for dental extractions without interrupting drug administration in patients undergoing oral Vitamin K antagonist chronic anticoagulant therapy. MATERIAL AND METHODS Randomized control trial of three hemostatic agents for dental extractions, in patients under oral anticoagulant therapy without drug interruption. The present study included 240 patients with international normalized ratio between 1.5 and 3.5. Patients took their anticoagulation drug normally. A single surgeon performed calibrated simple dental extractions and applied a plug of bismuth subgallate (BS), fibrin tissue adhesive (FTA) or microfibrillar collagen (MC), assigned randomly. Statistical analysis of bleeding between the groups was performed using the Chi-square test. RESULTS There was no hemorrhagic complication in the BS group, and only one in the FTA group. However, in the MC group, 10 patients (12.5%) suffered postoperative bleeding. Data analysis showed statistical differences between the MC group and the other two groups (P < 0.05). DISCUSSION BS and FTA showed similar clinical effectiveness and were more effective than MC for the control of postoperative bleeding in oral anticoagulated patients.
A prospective randomized study comparing fibrin sealant versus suture for conjunctival wound closure in orbital wall fracture surgery
International Journal of Oral and Maxillofacial Surgery. 2016;45((11):):1418-1423
The purpose of this randomized prospective study was to compare the clinical outcomes of orbital wall fracture surgery involving transconjunctival wound closure with fibrin sealant to the outcomes achieved with a conventional suture method. All surgeries were performed using the same technique, except that the conjunctival closure was achieved using either a buried 6-0 Vicryl suture (n=10) or fibrin sealant (n=10). The time to conjunctival closure and time required for complete wound healing were investigated. Postoperative discomfort in the two groups was compared at day 1, day 3, week 1, and week 4. Postoperative subconjunctival haemorrhage and peri-orbital ecchymosis were observed. The mean conjunctival closure time was significantly shorter in the fibrin group than in the suture group. All conjunctival wounds healed by the end of the first week. On postoperative days 1 and 3, the discomfort scores were significantly lower in the fibrin group. Subconjunctival haemorrhage and peri-orbital ecchymosis were less frequent in the fibrin group. Fibrin sealant proved to be as effective as sutures for conjunctival wound closure. Fibrin sealant allows a more comfortable early postoperative course and may be an excellent alternative for conjunctival wound closure in orbital wall fracture surgery.
Evaluation of fibrin sealant as a wound closure agent in mandibular third molar surgery-a prospective, randomized controlled clinical trial
International Journal of Oral & Maxillofacial Surgery. 2015;44((7)):871-5.
The aim of this randomized controlled trial was to assess the effectiveness of fibrin sealants in achieving haemostasis and wound closure following mandibular third molar extraction, in comparison with conventional suturing. Thirty patients with bilateral mandibular third molar impactions were recruited for the study. Using a split-mouth study design, wound closure following extraction was done using fibrin sealant on the study side and suturing on the control side. Sample allocation was done by simple randomization. The primary outcome measures were (1) the time taken to achieve wound closure and haemostasis and (2) postoperative mouth opening, pain, and swelling. Data analysis involved descriptive statistics and paired t-tests (P<0.05). IBM SPSS software (v.20.0) was used for the data analysis. The study group demonstrated a statistically significant reduction in duration to achieve haemostasis (1.2 vs. 251.9s; P<0.001) and wound closure (152.8 vs. 328.8s; P<0.001) in comparison with the control group. The study group also exhibited significantly reduced pain scores (2.0 vs. 3.5; P<0.001) and increased post-surgical mouth opening (P<0.001). No adverse effects of fibrin sealant were observed. In conclusion, fibrin sealant is a superior intraoral wound closure and haemostatic agent and a worthy alternative to suturing. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Effect on interleukin-1beta and interleukin-8 levels following use of fibrin sealant for periodontal surgery
Australian Dental Journal. 2014;59((2):):156-64.
BACKGROUND Fibrin sealant (FS) is a biologically derived tissue adhesive for securing flaps. The aim of the present randomized controlled clinical trial was to compare early wound healing by assessing interleukin-1beta (IL-1beta) and interleukin-8 (IL-8) levels from gingival crevicular fluid (GCF) after using FS and suture for periodontal flap closure. METHODS Thirty selected quadrants in 15 periodontitis patients were randomly assigned to either a test (fibrining) or control group (suturing) for flap closure. IL-1beta and IL-8 were assessed in GCF using enzyme-linked immunosorbent assay (ELISA) before and eight days after surgery. Patients were recalled at 7, 14, 21 days and 3 months after surgery for clinical assessment. RESULTS There was a statistically significant decrease in IL-1beta (84.82 + 77.18, 29.2 + 21.97 pg/mul) and IL-8 (57.94 + 55.47, 21.82 + 21.93 pg/mul) levels in the test side after fibrining while there was an increase in the control side (IL-1beta 31.40 + 16.82, 128.8 + 45.14; IL-8 31.40 + 16.82, 128.83 + 45.14 pg/mul) (p < 0.05). The change in concentration of IL-1beta and IL-8 following intervention correlated significantly in both the sites. Clinical parameters differed significantly only on the seventh day with less plaque and bleeding on the test sites. CONCLUSIONS Fibrin sealant enhances early wound healing by reducing inflammation after periodontal flap surgery. 2014 Australian Dental Association.
Effect of aerosolized fibrin sealant on hemostasis and wound healing after endoscopic sinus surgery: A prospective randomized study
American Journal of Rhinology & Allergy. 2014;28((4):):335-40.
BACKGROUND The purpose of this study was to investigate the effect of aerosolized fibrin sealant (FS) compared with that of polyvinyl acetal sponge packing on hemostasis and wound healing after functional endoscopic sinus surgery (FESS). METHODS We conducted a prospective randomized controlled trial of the use of aerosolized FS in 41 consecutive patients who underwent bilateral FESS between February 2011 and March 2012. The patients were randomized to receive FS applied via an aerosol spray in one nasal cavity and polyvinyl acetal sponge packing in the opposite cavity. The patients were followed up at 1, 2, 4, 8, and 12 weeks postoperatively. Crusting, adhesion, bleeding, granulation tissue formation, infection, and frontal sinus ostium stenosis after endoscopic surgery were assessed using a grading scale. Subjective symptoms related to nasal packing were evaluated using questionnaires quantified by visual analog scales. RESULTS The degree of granulation and crusting was significantly reduced in the side treated with FS compared with the polyvinyl acetal sponge side, as were bleeding and pain during nasal packing removal (p < 0.05). In addition, general satisfaction and willingness to reuse the material were significantly higher for the FS-treated side than for the polyvinyl acetal sponge-packed side (p < 0.001). CONCLUSIONS Compared with polyvinyl acetal sponge, aerosolized FS shows beneficial effects on hemostasis and wound healing after FESS. The application of FS resulted in a high degree of patient satisfaction without additional morbidity.
Fibrin sealant as an alternative for sutures in periodontal surgery
JCPSP, Journal of the College of Physicians & Surgeons - Pakistan. 2013;23((2):):164-5.
The trial compared wound healing clinically, histologically and morphometrically after the use of fibrin sealant and sutures for periodontal flap closure. Ten patients were selected for this split-mouth randomized controlled clinical trial. On the test site fibrin sealant (F) was applied for flap closure after periodontal flap surgery (n = 10) and on the control site sutures (S) were used (n = 10). Clinically wound healing was observed at 7, 14 and 21 days and biopsy was taken on the 8th day. At seventh day better healing was observed in fibrin sealant site. Histologically mature epithelium and connective tissue formation was seen in fibrin sealant site with increased density of fibroblasts (F = 70.45 +/- 7.22; S = 42.95 +/- 4.34, p < 0.001) and mature collagen fibers. The suture site had more number of inflammatory cells (S = 32.58 +/- 4.29; F = 20.91 +/- 4.46, p < 0.001) and more number of blood vessels (S = 11.89 +/- 3.64; F = 5.74 +/- 2.41, p = 0.005). Fibrin sealant can form a better alternative to sutures for periodontal flap surgery.
Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy
Aesthetic Surgery Journal. 2013;33((4):):487-96.
Background: Suction drains are commonly placed after rhytidectomy to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by crosslinking with extracellular matrix proteins, which may reduce the dead space under skin flaps. Objectives: The authors evaluate the safety and efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (Artiss; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, in improving flap adherence and reducing dead space in patients undergoing rhytidectomy. Methods: Patients with planned facial rhytidectomy were enrolled in this phase 3, prospective, controlled, randomized, patient-blinded, multicenter trial. They received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr on the other. Results: Seventy-five patients completed the trial. The mean (SD) drainage volume was 7.7 (7.4) mL from the sides treated with sealant and 20.0 (11.3) mL from the SoC-only sides (P < .0001). Rates of hematoma and seroma were similar for the 2 treatments, as were changes in postoperative skin sensitivity. Adverse events generally were mild; 2 serious adverse events were reported (wound abscess, dehydration). Conclusions: Adjunct use of FS VH S/D 4 s-apr in rhytidectomy was proven safe in this study. It significantly reduced drainage volumes without increasing the incidence of hematoma or seroma, which suggests that it eliminates dead space through improved flap adherence. Level of Evidence: 2.
Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy
Aesthetic Surgery Journal. 2013;33((3):):323-33.
BACKGROUND Suction drains are commonly placed after rhytidectomy surgery to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by cross-linking with extracellular matrix proteins, which may reduce the dead space under skin flaps. OBJECTIVES The authors evaluate the safety and preliminary efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (ARTISS; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, on tissue plane adherence and local hemostasis in rhytidectomy patients. METHODS In this phase 2, prospective, controlled, randomized, evaluator- and patient-blinded, multicenter study, 45 patients (of 56 possible enrollees) received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr treatment on the other side. Outcomes measures included visual assessments of ecchymosis (by blinded reviewers), grading of ecchymosis and edema, drainage volumes, occurrence of hematoma/seroma, safety evaluations, and patient-reported assessments of pain, numbness, and treatment preferences postoperatively. RESULTS Mean patient age was 55.1 years. Rates and grades of ecchymosis and edema were similar for the 2 treatments. The mean (SD) drainage volume 24 hours after surgery was 11.5 (13.7) mL from the FS VH S/D 4 s-apr-treated sides of the face and 26.8 (24.0) mL from the SoC-only sides (P < .0001). Patient assessments of pain, numbness, and preference favored treatment with FS VH S/D 4 s-apr. Adverse events were mild to moderate in severity. CONCLUSIONS Adjuvant use of FS VH S/D 4 s-apr appears to be safe and results in lower drainage volumes than SoC treatment alone.