NCT06865508

Brief Summary

does laser effect on alveolar osteitis recovery in oral contraceptive users ?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 4, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

alveolar osteitis and oral contraceptive

Outcome Measures

Primary Outcomes (2)

  • pain intensity by VAS

    Pain intensity measured using a Visual Analog Scale (VAS) at day0, day7, day14 post-treatment.

    4 weeks

  • Socket volume .

    measured using \[specific measurement technique, volumetric analysis\] at day0, day14 and 1-month post-treatment

    4 weeks

Secondary Outcomes (1)

  • Quality of life assessed

    4 weeks

Study Arms (2)

1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing.

EXPERIMENTAL

* 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 therapyDevice: zinc oxide eugenol dressing.

control group

ACTIVE COMPARATOR

zinc oxide eugenol dressing.

Device: zinc oxide eugenol dressing.

Interventions

Laser therapy was administered using a low-level laser device with the following parameters: \[ wavelength 980 nm810, power 500mw, and duration 90 seconds (30second for each 3 sides\].

1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing.

zinc oxide eugenol dressing.

1. Experimental Group: Laser therapy combined with zinc oxide eugenol dressing.control group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

physical therapy at Badr University in Cairo(BUC)

Cairo, 11829, Egypt

Location

MeSH Terms

Conditions

Dry Socket

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized clinical trial (RCT) designed to evaluate the effectiveness of laser therapy combined with zinc oxide eugenol dressing in comparison to zinc oxide eugenol dressing alone in the management of dry socket among females using oral contraceptives. The study assessed outcomes related to pain, quality of life, and socket volume.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 30, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations