NCT06622863

Brief Summary

Patients attending Dubai Dental Hospital and requiring nonsurgical periodontal therapy will be invited to take part in the study. Potential participants will be screened and selected based on the inclusion and exclusion criteria The aims of the randomized controlled trial are:

  • Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
  • Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups. The study will involve two stages, 1) Digital Avatar creation and 2) Clinical component. The participants will be randomly allocated to two equal sized groups (30 per group) using computer-generated numbers: Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics resident. Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

September 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 6, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

September 29, 2024

Last Update Submit

September 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plaque and bleeding score

    At baseline and after 3 months

Study Arms (2)

Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics res

ACTIVE COMPARATOR
Behavioral: Standard oral hygiene instructions will be given verbally by the periodontics resident

Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of t

EXPERIMENTAL
Behavioral: Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice

Interventions

Standard oral hygiene instructions will be given verbally by the periodontics resident

Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics res

Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice

Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of t

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or over.
  • Diagnosed with gingivitis or generalized periodontitis, Stage I-IV and Grade A-C.
  • Good compliance and commitment to attend follow-up review appointments.
  • Willing to provide informed consent.

You may not qualify if:

  • Received periodontal treatment in the last 12 months.
  • Received systemic anti-inflammatory or antibiotic treatment in the last 3 months.
  • History of malignancy, radiotherapy, or chemotherapy.
  • Pregnant or lactating women.
  • Use of medication known to cause gingival overgrowth.
  • Participants that require prophylactic antibiotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GingivitisPeriodontitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 2, 2024

Study Start

October 6, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

October 2, 2024

Record last verified: 2024-09