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Comparison Between Periodontal Effects of Fixed and Vacuum-Formed Retainers

Clinical Evaluation of Gingival and Periodontal Health of Lower Anterior Teeth With Fixed Retainer Versus Removable Retainer: A Randomized Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07650630
Enrollment
46
Registered
2026-06-16
Start date
2025-11-21
Completion date
2027-12-31
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic, Periodontal Health, Retainer

Brief summary

One of the most crucial aspects of orthodontic therapy is retention, which is required to prevent orthodontic relapse . There are two main types of retainers, removable retainer which depends on patient compliance to achieve proper results, and fixed retainer which can overcome the problem of patient compliance, but with using it there is higher risk of plaque accumulation and the process of brushing teeth becomes more complex. However, it is not known whether this necessarily leads to worsening of periodontal outcomes . The increasing use of permanent retainers and their requirement for continuous wear highlight the importance of evaluating their impact on the periodontal health but there is conflicting data available right now on how orthodontic retainers affect periodontal diseases

Detailed description

The purpose of this research is to compare the effect between fixed and removable retainer on periodontium as the current evidence on how these appliances affect periodontal health is still lacking significantly Orthodontic treatment plays an important role in enhancing the function, esthetics and overall well-being of patients. One of the most important elements of treatment is the retention phase. There are two main types of retainers that can be used in the retention phase either fixed or removable. At first banded fixed appliances were used as retainers , then in 1919 Hawly introduced removable retainers , then in 1973 Kneirim RW. introduced the first bonded retainer as enamel etching and modern adhesive systems facilitated the use of bonded retention . The most widely used removable retainer is the Hawley appliance, which is made of wire and acrylic resin. In 1971 Ponitz introduced fiber reinforced retainer which is less expensive, with better esthetics and easy to clean but it is not dimensionally stable and more prone to wearing. The duration of the retention phase frequently exceeds that of the active treatment. In many cases, orthodontists even propose lifetime retention. Removable retainers depend greatly on patient compliance so fixed compliance-free retainers were introduced but they cause more plaque accumulation and make the process of brushing teeth more complex, also there is conflicting data about their effect on periodontal health Artun was one of the first orthodontists to investigate the periodontal effect of fixed retainers. He found out that more plaque accumulation occurred with fixed retainers, but he suggested that plaque and calculus accumulation gingival to the retainer wire might not cause serious damage to the periodontium According to the most recent Cochrane review concerning this matter, most of the studies found no difference in periodontal measurements between the two types of retainers but one study found that the lower fixed retainer group had considerably more periodontal pocketing and bleeding on probing than the full-time lower removable retainer . Nevertheless, it is important to exercise caution when interpreting this periodontal pocketing outcome because the two groups were not similar at debonding, with four times as many participants in the fixed retainer group The most recent systematic reviews also concluded that the available evidence on this topic is inconclusive and that more research is needed which would help in choosing the suitable type of retainer for each patient as there are no specific guidelines for choosing one type of retainer over the other for each patient. But they concluded that fixed retainers are compatible with periodontal health, or at least not related to severe detrimental effects on the periodontium. It must also be taken in consideration several factors when interpreting the results of effect of fixed retainers on periodontal health like Hawthrone effect, limited follow up period and selection bias as most studies select people with good periodontal health . The concept of periodontal health was derived from Chapple et al. and is basically defined as having no clinical loss of attachment, limited bleeding on probing (\< 10%), and no significantly elevated probing depths (≤ 3 mm)

Interventions

Patients are given oral hygiene instructions during retention period , frequent follow up visits with patients

DEVICEvacuum retainer

Patients are given oral hygiene instructions during retention period , frequent follow up visits with the patients

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Minimal age of twelve years. * Presence of all mandibular anterior teeth from canine to canine. * Completion of orthodontic multi-bracket treatment with the requirement of retention of the mandibular anterior teeth. * Periodontal screening index ≤ 2 \[18\]. * Participation in all study visits.

Exclusion criteria

* Systemic disease potentially affecting the study outcome. * Conditions requiring antibiotic prophylaxis for clinical measurements that trigger transitory bacteremia. * Pregnant females. * Chronic use of medications affecting the study outcome. * Patients with active periodontal disease

Design outcomes

Primary

MeasureTime frameDescription
Probing depthimmediately after debonding and after 6 monthsAssessment of periodontal health using Periodontal probing depth Probing depth is measured in mms using periodontal probe, in a healthy periodontium pocket typically measures between 1 to 3 millimeters in depth
Bleeding on probingimmediately after debonding and after 6 monthsBleeding on probing is a 4 point scale Score 0: No bleeding No bleeding when you probe the gingival sulcus/pocket Score 1: Bleeding on probing Bleeding occurs after probing, usually within 10-30 seconds ,Mild bleeding at the gingival margin Score 2: Bleeding + profuse Bleeding is immediate, profuse, and often fills the sulcus, Or bleeding flows from the sulcus Score 3: Spontaneous bleeding, Bleeding occurs without any probing Seen before you even touch the tissue
gingival recessionimmediately after debonding and after 6 monthsLoss of clinical attachment level is measured as the distance in millimeters between the bottom of the pocket and the cementoenamel junction. Based on the extent of attachment loss, it can be categorized as light (1-2 mm), moderate (3-4 mm), or severe (5 mm or more) loss of clinical attachment.
Gingival indeximmediately after debonding and after 6 monthsGingival index is a 4-point scale in which scale 0 is healthy periodontium and scale 3 is severe inflammation.
plaque indeximmediately after debonding and after 6 monthsPlaque index is a 4-point scale in which scale 0 indicates the absence of plaque at the free gingival margin after drying, and scale 3 represents an abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface, including the interdental area

Secondary

MeasureTime frameDescription
patient satisfactionAfter 6 monthsAssessment of patient satisfaction using questionnaire.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026