Photo Biomodulation Therapy for Alveolar Osteitis Recovery in Oral Contraceptive Users

March 4, 2025 updated by: Doaa Saeed Mohamed, Badr University
does laser effect on alveolar osteitis recovery in oral contraceptive users ?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

photo biomodulation therapy for alveolar osteitis recovery in oral contraceptive users

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11829
        • physical therapy at Badr University in Cairo(BUC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

  • Inclusion Criteria:

Female patients aged 25-40 years. Currently using oral contraceptives for at least 3 months prior to participation.

Diagnosed with dry socket (alveolar osteitis) based on clinical criteria.

  • Exclusion Criteria:

Presence of systemic diseases (e.g., diabetes, immunodeficiency disorders). Smoking or tobacco use. Allergies to zinc oxide or other study materials. Use of antibiotics or anti-inflammatory medications within the last 2 weeks. Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing.
  • Laser therapy was administered using a low-level laser device with the following parameters: [ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides].
  • Zinc oxide eugenol dressing was applied immediately before the laser therapy.
  • The intervention will be performed at [specified intervals every day 0, day7, day 14, day 30)]
Device: Laser therapy
Laser therapy was administered using a low-level laser device with the following parameters: [ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides].
Device: zinc oxide eugenol dressing.
zinc oxide eugenol dressing.
Active Comparator: control group
zinc oxide eugenol dressing.
Device: zinc oxide eugenol dressing.
zinc oxide eugenol dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity by VAS
Time Frame: 4 weeks
Pain intensity measured using a Visual Analog Scale (VAS) at day0, day7, day14 post-treatment.
4 weeks
Socket volume .
Time Frame: 4 weeks
measured using [specific measurement technique, volumetric analysis] at day0, day14 and 1-month post-treatment
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessed
Time Frame: 4 weeks
Quality of life assessed using the Oral Health Impact Profile (OHIP-5) questionnaire at day0, day7and day14 post-treatment.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUC-IACUC-231015-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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