Direct versus indirect fixed retainer placement: bonding time, gum health, and retainer stability
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
This trial will test whether direct or indirect fixed retainer placement is quicker and leads to better gum health and fewer retainer failures for adults (18–40) finishing orthodontic treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 13 Years to 40 Years |
| Sex | All |
| Sponsor | Aga Khan University Hospital, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07107100 on ClinicalTrials.gov |
What this trial studies
This is a modified split-mouth randomized controlled trial at the Aga Khan University Hospital enrolling 60 adults finishing fixed orthodontic treatment. Each participant will receive one side bonded with a direct technique and the contralateral side bonded indirectly using a silicone jig/key, with bonding time recorded for each technique. Periodontal health will be tracked using gingival and plaque indices and retainer stability will be monitored for failures over the short-term follow-up. Recruitment is planned over approximately two months with clinical follow-ups covering the primary assessment period.
Who should consider this trial
Good fit: Adults aged 18–40 undergoing fixed orthodontic treatment with good oral hygiene who can attend follow-up visits and give informed consent are the ideal candidates.
Not a fit: Patients with periodontal disease, systemic illnesses, pregnant or nursing women, those with poor oral hygiene, or those unable to attend follow-up appointments are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a faster bonding method that preserves gum health and reduces retainer breakage for patients.
How similar studies have performed: Previous smaller studies have reported differences in gingival index and bonding outcomes between direct and indirect techniques, but this trial is novel in including the maxillary arch and a local population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Karachi, Sindh
- The Aga Khan University Hospital — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Fizzah Ikram, Bds
- Email: fizzahikram@outlook.com
- Phone: 923310243568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.