NCT05362591

Brief Summary

a 24 Patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (RBB) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (RBB) with minimal preparation protocol. (RBB) retention/survival, patient's speech as well as thermal sensitivity and patient's satisfaction will be evaluated for 12 month at 3,6,9 and 12 month.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

April 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 8, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

April 23, 2022

Last Update Submit

April 2, 2024

Conditions

Keywords

missing incisorsresin bonded bridge

Outcome Measures

Primary Outcomes (1)

  • resin bonded bridge retention/survival

    Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination.

    12 month

Secondary Outcomes (1)

  • Patient's satisfaction

    12 month

Study Arms (2)

resin bonded bridge with no preparation

EXPERIMENTAL

resin bonded bridge without enamel preparation

Procedure: resin bonded bridge with no preparation

resin bonded bridge with minimal preparation

ACTIVE COMPARATOR

resin bonded bridge with minimal preparation on tooth enamel

Procedure: resin bonded bridge with minimal preparation

Interventions

resin bonded bridge without enamel preparation

resin bonded bridge with no preparation

resin bonded bridge with minimal preparation of tooth enamel

resin bonded bridge with minimal preparation

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • Full set of permanent teeth.
  • Missing upper incisor
  • Controlled dental disease - no active caries or periodontal diseases
  • Patients will be available to be clinically reviewed up to 1 year

You may not qualify if:

  • Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
  • Patients with teeth missing opposite to the planned RBB
  • Abutment tooth mobility of 2 or greater (Millers classification)
  • Patients with debilitating illnesses or complicating medical conditions
  • Heavily restored tooth abutment not suitable for an RBB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October university for modern sciences and arts

Cairo, 12573, Egypt

Location

MeSH Terms

Conditions

Anodontia

Interventions

Denture, Partial, Fixed, Resin-Bonded

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Denture, Partial, FixedDenture, PartialDenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 5, 2022

Study Start

May 8, 2022

Primary Completion

May 4, 2024

Study Completion

June 1, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations