Van Yuzuncu Yil University
Van, 65080, Turkey (Türkiye)
NCT Number: NCT06119893
The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery
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Notify Me19 year–40 year
All sexes
Interventional
Not applicable
Van, 65080, Turkey (Türkiye)
Periodontitis is an oral inflamatuar disease caused by specific microorganisms, is characterized by attachment loss, alveolar bone resorption, pathological pocket formation. This disease causes deep periodontal pockets associated with deep intrabony defects as well as various clinical problems. For management overcome these problems, various approaches have been proposed in the treatment of periodontitis, including initial periodontal treatment such as scaling and root planing, followed by flap surgery, resective bone surgery and periodontal regeneration when applicable. However, periodontal flap surgery applied in these approaches causes undesirable side effects such as pain and swelling. To overcome these disorders, studies continue to investigate by using various medication regimens include pre, intra or post operative drugs.
Dexamethasone is a synthetic steroidal anti-inflammatory drug used to control pain, swelling, and inflammation occurring in third molar surgeries, periodontal therapy and periodontal surgeries, implant surgery, and endodontic treatment. In the literature, dexamethasone application is frequently used in oral surgery before or after third molar tooth extraction. There is limited research on dexamethasone applications in periodontal flap surgery. lt has been evaluated the effectiveness of oral use of etoricoxib and dexamethasone in preventing pain after open flap debridement surgery. Some authors used 4 mg dexamethasone tablets before mucoperiosteal flap surgery and reported that the pain level in the dexamethasone group was lower than placebo at the 3rd hour. It has been reported positive results where preferred its use intravenously in the postoperative management of periodontal surgery. However, to the investigators knowledge, there is no study in the literature in which dexamethasone is applied submucosally after periodontal flap surgery. Accordingly, the hypothesis of this study was that submucosal application of dexamethasone in periodontal flap surgery would have a positive effect on pain and patient comfort. In light of all these scientific data, this study aimed to evaluate the effect of submucosal dexamethasone application periodontal flap surgery on postoperative pain, swelling, chewing efficiency, trismus, healing and discomfort.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group.
Other names: Periodontal flap surgery
The mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group
Other names: Periodontal flap surgery
Time frame: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
Visual analogue scale (VAS) was assessed to monitor the degree of pain.VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain),
Time frame: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
101-point numeric rate scale (NRS-101) was assessed to monitor the degree of pain. NRS-101 is a 101-point numerical ratio scale that rates pain severity from 0 to 100. (0 = no pain to 100 = severe pain),
Time frame: Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation
Linear measurements were taken for swelling with a millimeter tape measure. Measurements were made between the angle of the mandible and the mentus, labial commissure, nasal ala, outer corner of the eye and tragus. The average of these five measurements was noted.
Time frame: It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation
For trismus evaluation, mouth opening was measured using a millimetric ruler by measuring the distance between the mesial-incisal corners of the upper right and lower right central incisors at the maximum jaw opening while the patient was sitting upright.
Time frame: It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation
Chewing efficiency was scored by the patients as 1) very poor, 2) poor, 3) good, 4) very good and 5) excellent.
Time frame: It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation
Healing at the operative site in terms of infection was scored by clinician as follows: 1) very poor, 2) poor, 3) good, 4) very good, and 5) excellent healing
Time frame: It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation
In the evaluation of discomfort, the four-point verbal rating scale (VRS-4) and a questionnaire questioning patient comfort were used. The questionnaire was scored with this four-point scoring system (Pain in this scoring: 1) none, 2) mild, 3) moderate, 4) severe).
Time frame: The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary
The number of analgesics used was noted by the patient in the pain diary.
Time frame: 14th day after operation
On the day of removing suture, the patients' general satisfaction levels were measured with a 5-point scale ( 1) poor, 2) reasonable, 3) good, 4) very good and 5) excellent).
Yuzuncu Yil University
Other
Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study
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