Direct versus indirect fixed retainer placement: bonding time, gum health, and retainer stability
Official title: 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
Run by Aga Khan University Hospital, Pakistan · NCT07107100 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 13 Years to 40 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Aga Khan University Hospital, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | August 10, 2025 |
| Study ends | August 21, 2025 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT07107100 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
The Aga Khan University Hospital
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Study coordinator: Fizzah Ikram, Bds
- Email: fizzahikram@outlook.com
- Phone: 923310243568
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gum recession in adults with and without prior orthodontic treatment
We will test which patient and tooth factors increase the chance of gum recession in adults who have or have not had orthodontic treatment.
-
How higher body mass index affects teens' braces, gums, and tooth health.
This project will test whether adolescents with higher BMI have more gum inflammation, tooth discoloration, and oral bacteria while wearing fixed braces.
-
Using specialized MRI for dental imaging
This study is testing a new type of MRI specifically for dental imaging to see if it can better diagnose dental problems compared to regular imaging methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.