NCT06990282

Brief Summary

The research idea is based on using micro-acupuncture therapy with ozone-treated olive oil to improve the condition of patients suffering from gingivitis and periodontitis and comparing it to the scientifically proven conventional treatment. This is a randomized controlled study, and this idea was chosen from the current general trend in medicine, particularly in dentistry, to use natural sources for treatment due to fewer side effects compared to the chemicals used.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 18, 2025

Last Update Submit

May 18, 2025

Conditions

Periodontal DiseasesPeriodontitis and Treatment NeedGingivitis

Outcome Measures

Primary Outcomes (3)

  • bleeding on probing

    Muehlemann \& Son index

    4 weeks

  • Plaque index

    Silness-Loe Plaque Index

    4 weeks

  • probing depth and clinical attachment loss

    measured in mm using a UNC 15 probe

    4 weeks

Secondary Outcomes (1)

  • malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.

    4 weeks

Study Arms (3)

biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.

EXPERIMENTAL

biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil

Other: microneedlingOther: scalingBiological: Ozonated olive oil

Periodontitis cases treated by scaling only.

EXPERIMENTAL

Periodontitis cases treated by (PMPR) only.

Other: scaling

Periodontitis cases treated with microneedling and topical ozonated olive oil.

EXPERIMENTAL

Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil.

Other: microneedlingOther: scalingBiological: Ozonated olive oil

Interventions

microneedlingOTHER

gingival microneedling (small holes in gingiva)

Periodontitis cases treated with microneedling and topical ozonated olive oil.biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.
scalingOTHER

scaling (plaque removal)

Periodontitis cases treated by scaling only.Periodontitis cases treated with microneedling and topical ozonated olive oil.biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.
Ozonated olive oilBIOLOGICAL

ozonated olive oil after microneedling

Periodontitis cases treated with microneedling and topical ozonated olive oil.biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years old
  • Male and female medically free participants
  • Patients suffering from biofilm induced gingivitis or periodontitis

You may not qualify if:

  • Smoking and tobacco related habits
  • Non-biofilm induced gingival diseases
  • Necrotizing periodontal diseases
  • periodontitis as a manifestation of systemic disease
  • Third molar tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisGingivitis

Interventions

Percutaneous Collagen InductionTooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitationDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Nayroz Tarrad, Prof

    Fayoum University

    STUDY DIRECTOR

Central Study Contacts

heba Alnjar

CONTACT

+201023717086hmh14@fayoum.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: microneedling and ozonated olive oil
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

July 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

upon request

Shared Documents
STUDY PROTOCOL
Time Frame
after publication of the final results
Access Criteria
upon request

Locations

EG(1)