NCT06741696

Brief Summary

This double-blind, single-center, split-mouth, randomized prospective clinical trial was conducted among 48 systemically and periodontally healthy patients who had bilaterally asymptomatic mandibular third molars.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

October 24, 2024

Last Update Submit

December 15, 2024

Conditions

Keywords

3rd molar surgery, saline irrigation at different temperatures

Outcome Measures

Primary Outcomes (1)

  • post operative pain after 3rd molar surgery

    Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded

    7 days

Study Arms (2)

group 1

OTHER

randomly selected group 1

Procedure: Surgical extractionProcedure: saline irrigations

group 2

OTHER

randomly selected group 2

Procedure: Surgical extractionProcedure: saline irrigations

Interventions

saline irrigation at different temperatures

group 1group 2

saline irrigation done after 3rd molar surgery

group 1group 2

Eligibility Criteria

AgeUp to 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Patients with complicating systemic disease ( American Society of Anesthesiologists : 3- 6). 2. Patients who have second molars with severe periodontal defect or deep periodontal pocket (probing depth \>4 mm). 3. Patients with poor oral hygiene. 4. Patients with a history of using analgesics 12 hours ago or antibiotics 1 month before. 5. The presence of cysts or tumors around the impacted third molar.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • hafsa razzaq razzaq, BDS

    Armed Forces Institute of Dentistry , Rawalpindi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hafsa razzaq Razzaq, BDS

CONTACT

Kanza zafar Zafar, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Hafsa Razzaq, RESIDENT ORAL MAXILLOFACIAL SURGERY

Study Record Dates

First Submitted

October 24, 2024

First Posted

December 19, 2024

Study Start

October 24, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations