Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients

NCT07107100 | Recruiting DMC

• 2 other identifiers: 2024-9292-32612375
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The placement technique of retainers in both maxillary and mandibular arches can influence the time taken for bonding the retainer in the mouth of a patient which can in turn affect the patient´s response to the procedure. The different placement techniques can influence the stability of the retainer wire on teeth and the maintenance of periodontal health during the retention period. Therefore, it is essential to know which technique is better suited for placement and its influence on periodontal health so that in the future it helps clinicians save their time during placement of retainers while benefiting the patients. To our knowledge, this will be the first study both locally and internationally that will include an assessment of periodontal health, time duration of placement and stability of fixed retainer in the maxillary arch as well. Three months period is sufficient for assessment of periodontal health and failure of retainer, long term studies can be at a risk of attrition bias. OBJECTIVES: The objectives of this study are:

• The primary objective of this study is to compare the failure of fixed retainers, along with periodontal health and bonding time, which are bonded either through direct method or indirect method on patients undergoing orthodontic debonding through a modified split-mouth technique using mean values for plaque index, gingival index, calculus index follow up appointments over a period of three months.
• The secondary objective of the study is to assess the amount of time taken during placement of retainers via both direct and indirect bonding of fixed retainers

Conditions

Orthodontic Treatment

Keywords

fixed retainer, retainer breakage

Outcome Measures

Primary Outcomes (1)

• Assessment of retainer failure

  using the frequency of breakage of retainer wire, we will assess retainer failure

  3 months with 3 follow ups, one at the time of placement and one at 1 month, next on 3rd month

Study Arms (2)

control

OTHER

those in which fixed retainer is placed using conventional method

Other: a silicon jig/key is used to place/bond fixed retainer on teeth

Silicon Jig

EXPERIMENTAL

those in which fixed retainer was placed using a silicon jig

Other: a silicon jig/key is used to place/bond fixed retainer on teeth

Interventions

a silicon jig/key is used to place/bond fixed retainer on teeth OTHER

a silicon jig/key is used to place/bond fixed retainer on teeth

Silicon Jig; control

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged between 18 - 40 years
• Patients who read, write and understand English language
• Patients undergoing fixed orthodontic treatment
• Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices at the time of debonding of brackets.
• All patients who will sign the informed consent form

You may not qualify if:

• Patients with periodontal disease
• Patients with any systemic disease
• Pregnant or nursing females
• Patients who cannot come for follow up appointments for a retainer check up

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

The Aga Khan University Hospital

Karachi, Sindh, 75290, Pakistan

RECRUITING

Central Study Contacts

FIZZAH IKRAM, BDS

CONTACT

923310243568; fizzahikram@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: August 6, 2025
• Study Start: January 1, 2024
• Primary Completion: August 10, 2025
• Study Completion: August 21, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: august 2025 till december 2025
• Access Criteria: Principal Investigator

Locations

PA (1)