Comparison Between Periodontal Effects of Fixed and Vacuum-Formed Retainers

NCT07650630 | Active Not Recruiting DMC

• 1 other identifier: ??1125
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Orthodontic; Retainer; Periodontal Health

Outcome Measures

Primary Outcomes (5)

• Probing depth

  Assessment 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

  immediately after debonding and after 6 months

• Bleeding on probing

  Bleeding 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

  immediately after debonding and after 6 months

• gingival recession

  Loss 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.

  immediately after debonding and after 6 months

• Gingival index

  Gingival index is a 4-point scale in which scale 0 is healthy periodontium and scale 3 is severe inflammation.

  immediately after debonding and after 6 months

• plaque index

  Plaque 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

  immediately after debonding and after 6 months

Secondary Outcomes (1)

• patient satisfaction

  After 6 months

Study Arms (2)

intervention group ( fixed retainer group)

ACTIVE COMPARATOR

* At first, medical and dental histories will be taken from the patients then extra- and intra-oral examinations will follow. * Brackets are removed using a plier at the end of active orthodontic treatment. * Excess adhesive material is removed using finishing stones and rubber polishing kit. * Polishing the teeth before placement of retainer. For the fixed retainer group, it will be fabricated from a stainless-steel alloy and applied to each lingual tooth surface from one mandibular canine to the contralateral canine. The patients' teeth surfaces will then be prepared using 37% phosphoric acid etchant gel for 30 seconds, rinsed and dried with oil-free compressed air for 10 seconds. After drying the enamel surfaces, a bonding agent will be applied using a micro-brush, spread using oil-free compressed air followed by the application of the adhesive material and placement of the fixed retainer. After light curing excess adhesive material will be removed.

Device: Fixed retainer

control group ( vacuum retainer group)

ACTIVE COMPARATOR

At first, medical and dental histories will be taken from the patients then extra- and intra-oral examinations will follow. * Brackets are removed using a plier at the end of active orthodontic treatment. * Excess adhesive material is removed using finishing stones and rubber polishing kit. * Polishing the teeth before placement of retainer. For the removable retainer group the mandibular removable retainers will be fabricated using thick thermoplastic vacuum-formed sheets, patients will be instructed to wear them full- time.

Device: vacuum retainer

Interventions

Fixed retainer DEVICE

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

intervention group ( fixed retainer group)

vacuum retainer DEVICE

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

control group ( vacuum retainer group)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: November 21, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

EG (1)