NCT02066337

Brief Summary

To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

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

March 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

January 30, 2014

Last Update Submit

February 19, 2014

Conditions

Periodontal Diseases

Keywords

Ozone gelAntioxidantsChronic periodontitisSuperoxide dismutase

Outcome Measures

Primary Outcomes (1)

  • Superoxide dismutase activity

    Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.

    6 months

Secondary Outcomes (5)

  • Plaque Index

    6 months

  • Gingival index

    6 months

  • Probing pocket depth

    6 months

  • Clinical attachment level

    6 months

  • Bone density

    6 months

Study Arms (2)

placebo gel

PLACEBO COMPARATOR

scaling and root planing with placebo gel

Procedure: scaling and root planingDrug: placebo gel

Ozonated olive oil gel

ACTIVE COMPARATOR

scaling and root planing with Ozonated olive oil gel

Procedure: scaling and root planingDrug: Ozonated olive oil gel

Interventions

scaling and root planingPROCEDURE
Ozonated olive oil gelplacebo gel
placebo gelDRUG
placebo gel
Ozonated olive oil gelDRUG
Also known as: Ozonated olive oil gel = Oxactiv gel
Ozonated olive oil gel

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant's age ranged between 30 and 60 years.
  • All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
  • Willingness to participate and sign the informed consent.

You may not qualify if:

  • Any systemic disease that affect the periodontium.
  • Pregnancy, lactation, postmenopausal women
  • People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
  • People who use mouth washes regularly
  • Heavy smoking (\> 10 cigarettes/day)
  • History of alcohol abuse.
  • Participation in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontal DiseasesChronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Enas Elgendy, ph.D

    October 6 University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecuture, October 6 University

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 19, 2014

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

EG(1)