The Use of Submucosal Dexamethasone After Periodontal Surgery

NCT06119893 | Completed

• 1 other identifier: 13.07.2021/08
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Pocket; Pain; Swelling/ Edema; Patient Satisfaction; Periodontitis

Keywords

pain; dexamethasone; surgical flaps

Outcome Measures

Primary Outcomes (3)

• VAS

  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),

  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

• NRS-101

  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),

  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

• Swelling

  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.

  Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation

Secondary Outcomes (6)

• Trismus

  It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation

• Chewing efficiency

  It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation

• Healing of operation area

  It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation

• Discomfort

  It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation

• Analgesics consumed

  The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the control group, 2 mL 0.9% isotonic sodium chloride (saline) with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation

Drug: submucosal 2 mL 0.9% isotonic sodium chloride application

Test Group

ACTIVE COMPARATOR

Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the test group, 8 mg (2 mL) submucosal dexamethasone with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation

Drug: submucosal 8 mg (2 mL) dexamethasone application

Interventions

submucosal 8 mg (2 mL) dexamethasone application DRUG

The mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group.

Also known as: Periodontal flap surgery

Test Group

submucosal 2 mL 0.9% isotonic sodium chloride application DRUG

The mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group

Also known as: Periodontal flap surgery

Control Group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pocket depth ≥5mm;
• systemically healthy;
• without drug allergy;
• without any blood disease;
• not using medication (anti-platelet, anticoagulant, immunosuppressant medication);
• received no any periodontal surgery in the last 6 months;

You may not qualify if:

• poor oral hygiene;
• smoking;
• any systemic disease that would affect the surgical operation;
• problem with the kidneys or adrenal glands;
• connective tissue disease or immunodeficiency;
• breastfeeding period or pregnancy.
• high dental anxiety

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

Location

Related Publications (4)

• Vieth MP, Deas DE, Archontia Palaiologou A, Diogenes A, Mader MJ, Mealey BL. Effect of intravenous dexamethasone on postoperative pain and swelling following periodontal flap surgery: A randomized controlled trial of patient-centered outcomes. J Periodontol. 2022 Feb;93(2):237-245. doi: 10.1002/JPER.21-0153. Epub 2021 Jun 3.

  PMID: 34021915 BACKGROUND

• Steffens JP, Santos FA, Pilatti GL. Postoperative periodontal pain prevention using two dexamethasone medication protocols: a double-blind, parallel-group, placebo-controlled randomized clinical trial. Am J Dent. 2011 Dec;24(6):354-6.

  PMID: 22263332 BACKGROUND

• Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28.

  PMID: 31702056 BACKGROUND

• Altindal D, Alsafadi A, Alshujaa B, Talmac AC, Ege B, Calisir M, Alpaslan NZ. Effect of submucosal dexamethasone on postoperative pain, swelling and trismus after periodontal surgery: a randomized clinical study. Clin Oral Investig. 2024 Dec 4;28(12):681. doi: 10.1007/s00784-024-06076-5.

  PMID: 39627624 DERIVED

MeSH Terms

Conditions

Periodontal Pocket; Pain; Edema; Patient Satisfaction; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dicle Altindal, DDS

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

• Anas ALSAFADI, PhD

  Special dental clinic

  STUDY CHAIR

• Basem ALSHUJAA, PhD

  Special dental clinic

  STUDY CHAIR

• Ahmet Cemil Talmac, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Bilal Ege, PhD

  Adiyaman University

  STUDY CHAIR

• Metin Calisir, PhD

  Adiyaman University

  STUDY CHAIR

• Nazli Zeynep Alpaslan, PhD

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Assistant Professor

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: August 12, 2021
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)