Actively Recruiting
Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients - A Modified Split-mouth Randomized Controlled Trial
Led by Aga Khan University Hospital, Pakistan · Updated on 2025-08-06
30
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different techniques for placing fixed retainers in patients undergoing orthodontic treatment. The study focuses on comparing the failure rates of retainers, the time taken to bond them, and the impact on periodontal health over a three-month period. This is a modified split-mouth randomized controlled trial conducted to determine which placement method offers better stability and periodontal outcomes for patients after debonding braces. The study compares two groups: one where retainers are placed directly without lab work, and another where retainers are made in a lab and transferred to the teeth using a silicon jig. Both maxillary and mandibular arches are involved, with random assignment of placement technique to different sides of the mouth. Bonding time is measured using a timer, and oral hygiene instructions are provided to all participants. Follow-ups occur at one month and three months to assess retainer failure and periodontal health. Participants will have assessments at the time of retainer placement, one month, and three months after placement. These include measurements of plaque index, gingival index, calculus index, and evaluation of retainer stability. Data are collected using standardized forms and analyzed to compare the two methods. Safety monitoring includes advising participants to report any issues with the retainer wire, such as movement or irritation. The total involvement duration for each participant is about three months with three follow-up visits.
CONDITIONS
Brief Title
Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 months
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Placement day with assessments at 1 month and 3 months after
Participants receive a fixed retainer placed either by the conventional direct method or using a silicon jig (indirect method). Periodontal health and bonding time are assessed at placement.
3 visits (in-person): at placement, 1 month follow-up, and 3 months follow-up
Trial Site Locations
Total: 1 location
1
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 75290
Actively Recruiting
Research Team
F
FIZZAH IKRAM, BDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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