Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel

NCT ID: NCT06582069

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, And based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Discoloration, Tooth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bleaching with 2% kiwi extract.

The fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate.

This concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C.

The extract thus collected will be stored at 4°C till further use.

Group Type EXPERIMENTAL

Bleaching

Intervention Type DEVICE

Bleaching

bleaching using 2,350 ppm ozone gas.

A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine.

The ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment.

Ozone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans

Group Type EXPERIMENTAL

Bleaching

Intervention Type DEVICE

Bleaching

bleaching with 2% kiwi extract followed By 2,350 ppm ozone gas.

The fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate.

This concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C.

The extract thus collected will be stored at 4°C till further use. A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine.

The ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment.

Ozone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans.

Group Type EXPERIMENTAL

Bleaching

Intervention Type DEVICE

Bleaching

bleaching with 38% hydrogen peroxide.

Application of 38% H2O2 gel for 20 minutes. Then, the H2O2 gel will be removed, and teeth will be sprayed for 10 seconds with water from a 3-in-1 syringe

Group Type EXPERIMENTAL

Bleaching

Intervention Type DEVICE

Bleaching

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bleaching

Bleaching

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A total of the 40 participants aged between (18-35 years) with no gender prediction.
* The participation will be entirely voluntary, and a signed statement of informed consent will be obtained prior to the start of the study.
* Systemically healthy subject based on medical and drug histories, a subject requiring scaling and polishing with moderate calculus with at least two non-adjacent hypersensitive teeth with Schiff scale scores \>1 with air blast stimulus.
* Access to sound maxillary anterior teeth.
* Vitapan classical shades should be A3 or darker and lighter shades are not included.

Exclusion Criteria

* Participants with poor oral hygiene.
* Participants with missing anterior teeth.
* Participants with unrealistic expectations.
* Participants with dental caries, those undergoing orthodontic treatment.
* Participants with a history of periodontal treatment, pregnant or lactating women and individuals with a history of asthma.
* Those who are allergic to kiwi or ozone skin therapy were excluded from the study.
* Smokers are excluded from the present study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mona Bedier El Lakanay

Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24/3/2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Quercetin in Treatment of Periodontitis
NCT05928546 NOT_YET_RECRUITING PHASE1