## Protocol Section
### Identification Module
**NCT ID:** NCT06432712

**Brief Title:** Comparison of Post Operative Endodontic Pain in Patients With Irreversible Pulpitis Treated With and Without Dexamethasone.

**Official Title:** Comparison of Post Operative Endodontic Pain in Patients With Irreversible Pulpitis Treated With and Without Dexamethasone.

#### Organization Study ID Info
**ID:** FUCDCLINIC-2404
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2025-06-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Foundation University Islamabad

#### Lead Sponsor

**Class:** OTHER

**Name:** Shoaib Rahim

#### Responsible Party

**Investigator Affiliation:** Foundation University Islamabad

**Investigator Full Name:** Shoaib Rahim

**Investigator Title:** Assistant professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Root canal procedure is a common procedure in dentistry. Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain.

Potential Solution: The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain.

Research Goal: Pain score of patients treated with dexamethasone infiltration will be less compared to patients treated with NSAIDS alone after canal instrumentation.

**Detailed Description:** Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. The peak inflammatory response occurs after 24 - 48 hours of root canal instrumentation. As management of post-endodontic pain is still a challenge for clinicians several drugs which include NSAIDs, acetaminophen, opioids and steroids are used to reduce the inflammatory response. Corticosteroids possess anti-inflammatory efficacy, and they prevent the production and release of inflammatory mediators at the site of tissue injury thus reducing the signs \& symptoms of inflammation such as pain, swelling \& loss of function. Dexamethasone is a potent corticosteroid that has the ability to reduce the production of proinflammatory cytokines. Dexamethasone can be administered orally, or as an intraosseous, intra ligament periapical \& intracanal injection. Dexamethasone is effective in alleviating pain in first 24 hours post endodontic treatment. Previous research on the effect of dexamethasone injection on post-endodontic treatment pain in patients presenting with necrotic pulp treated with single visit endodontic treatment reported 25% post operative pain occurrence and 9% when treated with dexamethasone.

Study Goal : The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain as compared to the prescription of NSAIDs only. If dexamethasone infiltration is effective in pain relief after endodontic treatment, it can be a useful adjunct in managing patients presenting with acute pulpal pain.

### Conditions Module

**Conditions:**

- Pain

**Keywords:**

- Postoperative Pain

- Root canal therapy

- Dexamethasone

- Pulpitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive dexamethasone infiltration or only analgesic therapy. They will remain in their assigned group throughout the study.

##### Masking Info

**Masking:** NONE

**Masking Description:** Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in this arm will receive routine root canal treatment with a prescription of NSAIDs post operatively.

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Participants in this arm will receive routine root canal treatment along with 2.5ml of dexamethasone 4mg/ml peri apical infiltration with a prescription of NSAIDs post operatively.

**Intervention Names:**

- Drug: Dexamethasone 4mg

**Label:** Experimental

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental

**Description:** 2.5ml of Dexamethasone 4mg/ml will be administered via periapical infiltration with a 23 gauge needle to the experimental group.

**Name:** Dexamethasone 4mg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The patient's pain response before treatment will be recorded using visual analogue scale 0-10.Pain score of 3 and less than 3 will be categorized as no postoperative pain and score greater than 3 will be categorized as post operative pain.

**Measure:** post operative pain

**Time Frame:** 12 hours, 24 hours and 1 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients of age 18-50 years
* Maxillary molar and premolar teeth
* Pt diagnosed with irreversible pulpitis with or without apical periodontitis

Exclusion Criteria:

* Teeth with calcified canals.
* Teeth with incompletely formed apices.
* Teeth requiring retreatment.
* Taking analgesics, anti-inflammatory, or tri-cyclic anti-depressants for their medical conditions.
* Teeth with grade II or III mobility (more than 2 mm)
* Pregnant patients
* Pt who are immunocompromised (uncontrolled diabetes mellitus, renal impairment)

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zainabbutt05@gmail.com

**Name:** zainab butt, BDS

**Phone:** +93225667847

**Role:** CONTACT

**Contact 2:**

**Email:** rozina.nazir@fui.edu.pk

**Name:** Rozina Nazir, FCPS

**Phone:** +92 3215376612

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12.

**PMID:** 32976660

**Citation:** Yeganegi S, Fazelian N, Layegh Nejad MK, Manzouri L. Comparison of the Efficacy of Dexamethasone and Methylprednisolone in Infiltration Injection for Postendodontic Pain in Patients with Necrotic Pulp: A Randomized Controlled Clinical Trial. Pain Res Manag. 2022 Feb 23;2022:4163120. doi: 10.1155/2022/4163120. eCollection 2022.

**PMID:** 35251416

**Citation:** 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

**Citation:** Nogueira BML, Silva LG, Mesquita CRM, Menezes SAF, Menezes TOA, Faria AGM, Porpino MTM. Is the Use of Dexamethasone Effective in Controlling Pain Associated with Symptomatic Irreversible Pulpitis? A Systematic Review. J Endod. 2018 May;44(5):703-710. doi: 10.1016/j.joen.2018.02.006. Epub 2018 Mar 20.

**PMID:** 29571913

**Citation:** Yavari HR, Jafari F, Jamloo H, Hallaj-Nezhadi S, Jafari S. The Effect of Submucosal Injection of Corticosteroids on Pain Perception and Quality of Life after Root Canal Treatment of Teeth with Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2019 May;45(5):477-482. doi: 10.1016/j.joen.2019.01.005. Epub 2019 Mar 23.

**PMID:** 30910353

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003788

- Term: Dental Pulp Diseases

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M14525

- Name: Pulpitis

- Relevance: HIGH

- As Found: Pulpitis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M6984

- Name: Dental Pulp Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011671

- Term: Pulpitis

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

### Misc Info Module

- Version Holder: 2024-05-31
