Category
»
Primary study
Registry of Trials»clinicaltrials.gov
Year
»
2025
Gingival enlargement leads to unaesthetic appearance, increased susceptibility toperiodontal disease and halitosis by making it difficult to control plaque, and chewingand speech disorders by affecting functional function. Gingivectomy and gingivoplasty areused for the excision of diseased gingiva or gingival enlargement to create a naturalanatomical form of the gingiva and improve aesthetics. After gingivectomy andgingivoplasty surgery, secondary healing occurs at the wound site. Bleeding and pain as aresult of secondary healing negatively affect the patient's quality of life. Manydifferent treatment methods such as ozone therapy, laser therapy, antiseptic agents,platelet concentrate, and herbal products are applied to reduce postoperativecomplications and increase patient comfort after gingivectomy and gingivoplasty. Sinceozone gas increases growth factors, activates local antioxidant mechanisms, and supportstissue repair, its application to the wound site prevents postoperative infection and mayaccelerate wound healing. Topical application of ozone gas has been reported to beeffective in the early stages of wound healing by increasing the amount of vascularendothelial growth factor expression. In a systematic review aiming to evaluate theeffectiveness of ozone therapy in reducing the symptoms of oral diseases, especially oralmucositis, which is a serious complication of cancer treatment, it was confirmed thatozone has analgesic, anti‐inflammatory, antimicrobial, and regenerative properties. In astudy, it was found that the application of ozone therapy after gingivectomy andgingivoplasty reduced the pain levels of patients and positively affected their qualityof life. To compare the healing potential of the wound surface following gingivectomy andgingivoplasty surgery applied to the maxillary anterior regions with the application ofclassical periodontal paste (Coe‐pak) using activated oxygen (Cure 09 Active Oxygen) andwith the application of classical periodontal paste (Coe‐pak) alone.The study will include 48 systemically healthy, systemically healthy patients older than18 years of age, with gingival enlargement in the maxillary anterior region, requiringgingivectomy and gingivoplasty surgery, who applied to Kütahya University of HealthSciences, Faculty of Dentistry, Department of Periodontology and İzmir DemocracyUniversity, Faculty of Dentistry, Department of Periodontology. All patients will becalled for re‐evaluation 4 weeks after phase 1 periodontal treatment and surgicaltreatment will be planned. Clinical measurements (plaque index, gingival index, pocketdepth, bleeding index on probing, and gingival overgrowth index) and oral health impactprofile‐14 questionnaire will be recorded and standard photographs will be taken beforesurgery. After local anesthesia, the incision line will be determined with a markingpress or periodontal probe according to the amount of gingival enlargement. An externalbeveled incision will be made along the determined incision line with a No. 15 scalpel.Once the incision is complete, the surrounding tissues will be cleaned usingmicrosurgical scissors. Following this, gingivoplasty will be performed. Patients will berandomly assigned to either the test group or the control group. In the test group,periodontal paste (Coe‐Pak) will be applied to the area designated for secondary healingafter ozone therapy (Cure 09 Active Oxygen). In the control group, only periodontal paste(Coe‐Pak) will be applied. Postoperatively, the patient will record the bleeding status,daily analgesic use, and pain and burning with a visual analog scale for the first 7days. Standard photographs will be taken in the postoperative period, immediately afterthe placement of the patch and on the 7th, 14th and 21st days. In addition, clinicalevaluations (healing index, inflammation, modified manchester scar scale, surgical AreaPlaque index, re‐epithelialisation evaluation, and only on the 7th day, plaqueaccumulation in the periodontal paste) will be recorded from the patients on the 7th,14th, and 21st days.
Epistemonikos ID: 618652865198255ad1467e2d98c57135e6f2a2fd
First added on: Mar 27, 2025