Evaluation of Anti Bacterial Effect of Titanium Dioxide Nanoparticles on Baseplates of Twin Block

NCT06051487 | Completed

• 1 other identifier: Dentist
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background The objective of this study was to evaluate the antibacterial effect of Titanium dioxide nanoparticles incorporated into the acrylic baseplates of maxillary part of twin block appliances in orthodontic patients during the treatment period. Material and methods Twenty-six patients were selected randomly and divided into two groups(n=13). Test group patients were used orthodontic functional appliances containing Titanium dioxide nanoparticles in acrylic baseplates. Control group patients were used orthodontic functional appliances without Titanium dioxide nanoparticles in acrylic baseplates. Swap samples were taken from palatal gingiva facing fitting surface of acrylic component of maxillary part of twin block appliance for each patient at five times intervals (base line sample, after one, two, four, and six months) then cultured in blood agar plates to calculate bacterial colony count.

Conditions

Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• Bacterial colony count

  Changes in bacterial colony count under acrylic base plate in Participants using twin block appliance containing titanium dioxide nanoparticles in comparison to participant using appliance not containing titanium dioxide nanoparticles

  samples was taken within five time intervals (base line samples, at one month, at two months, at four months, at six months)

Study Arms (2)

Titanium dioxide nanoparticles containing group

OTHER

participants using twin block appliance in which titanium dioxide nanoparticles added to acrylic baseplates to evaluate its antibacterial effect

Other: titanium dioxide nanoparticles in test group

control

OTHER

participants use twin block appliance without any addition to acrylic base plates

Other: titanium dioxide nanoparticles in test group

Interventions

titanium dioxide nanoparticles in test group OTHER

Titanium dioxide nanoparticles added to acrylic baseplate in test group

Titanium dioxide nanoparticles containing group; control

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• early permanent dentition (ages 9 to 14)
• mandibular retrusion-related class II skeletal deformity
• overjet more than 4mm

You may not qualify if:

• systemic diseases
• congenital craniofacial deformity
• inflammatory or infectious diseases within the previous month
• taking medication in the last month, such as fluoride or antibiotics
• frequent consumers of sorbitol- and xylitol-containing products
• mouth rinses
• unusual or specific dietary habits
• cleft lip or palate
• unusual habits or previous orthodontic treatment.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ghada M Elabd

  Master degree student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: March 11, 2022
• Primary Completion: October 11, 2022
• Study Completion: April 25, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

EG (1)