Retentive Capacity of Bonded Retainer Vs Vacuum-formed and Combined Bonded-vacuum Retainers

NCT06476574 | Recruiting

• 1 other identifier: derosuperstar123
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal is to test the differences between the retentive capacity of fixed retainer, vacuum-formed retainer \& combination of both; and recommend the most effective protocol for retention of lower incisors crowding treated by non-extraction treatment plan The main question is: In patients with lower incisors crowding treated by non-extraction treatment plans, what is the difference in retentive capacity between fixed retainer, vacuum formed retainer and combined bonded and vacuum retainers in maintaining corrected lower anterior segment crowding? After enrolment, each participant will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished. An alginate impression will be taken to be poured into a study model which will be scanned to obtain STL files for digital models. All patients will have periodontal charting and probing depths recorded for the lower anterior segment. According to the randomization, each patient will be assigned to a group to receive the retainer. All patients will be called for follow-up after 1 week, 1 and 3 months.

Conditions

Orthodontic Retainer; Fixed Orthodontic Retainer; Orthodontic Relapse; Essix Retainer; Vacuum-formed Retainer; Dual Retention Protocol

Outcome Measures

Primary Outcomes (1)

• The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months

  The stability of the orthodontic treatment result and the degree of relapse will be measured by superimposition of the digital model at each time point on the initial model after debonding at T0.

  Relapse will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

Secondary Outcomes (4)

• Patient's compliance

  It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• Periodontal health

  It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• The integrity of the retainers

  It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• Patient's satisfaction

  It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

Study Arms (3)

Vacuum-formed retainer

EXPERIMENTAL

An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.

Device: Vacuum-formed retainer

Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.

EXPERIMENTAL

A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.

Device: Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.

Lingual bonded retainer from canine-to-canine

ACTIVE COMPARATOR

A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors.

Device: Lingual bonded retainer from canine-to-canine

Interventions

Vacuum-formed retainer DEVICE

* After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done. * An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. * The retainer will be finished and delivered to the patient. * The patient will be instructed to wear the retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement; and he will be supplied with a check list to evaluate the compliance and to calculate the wearing hours. * Another alginate impression will be taken for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (before wearing of the retainer).

Vacuum-formed retainer

Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. DEVICE

* A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used \& it will be finished and delivered to the patient. * The patient will be instructed to wear the Vacuum retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the bonded retainer; and will be supplied with a check list to evaluate the compliance and to calculate the wearing hours. * Another alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0.

Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.

Lingual bonded retainer from canine-to-canine DEVICE

* After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done. * A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors. * The patient will be instructed to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the retainer. * An alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer).

Lingual bonded retainer from canine-to-canine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients
• Finished non-extraction orthodontic treatment
• Full set of permanent dentition (excluding third molars).
• Good oral hygiene
• No restorations on lower anterior teeth or morphologic crown anomalies.
• Little's irregularity index score 0

You may not qualify if:

• Systemic disease or drugs affecting periodontal health.
• Smokers
• Poor oral health that precludes orthodontic treatment (presence of caries, active white spots,or periodontal diseases)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• Hadeer A. ElBehery, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Fady H. Fahim, Ass Professor

  Cairo University

  STUDY DIRECTOR

• Sally M. Reyad, Lecturer

  Cairo University

  STUDY CHAIR

Central Study Contacts

Hadeer A. ElBehery, Bachelor

CONTACT

+201064618667; hadeer.elbehery@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree student, Orthodontics department, Faculty of dentistry, Cairo University

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 26, 2024
• Study Start: September 29, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

EG (1)