NCT04853459

Brief Summary

Since the teeth loss leads to disability \& impairment, and teeth restoration lead to improvement in the life quality throughout the oral health improvement. The acceptable function of a complete denture on great extent depends on impression technique which includes the maximum coverage of denture supporting areas and making a combination of managing movable soft tissues along with different kinds of impression materials and techniques for accurate reproduction of oral foundation. Border molding considered to be as an important step in the in complete denture fabrication, since the retention of complete dentures depend on several factors, as the biological, physical and mechanical, these factors could be achieved by mean of an accurate border molding followed by an accurate final impression. The border molding technique is the shaping of the border areas of a custom impression tray by manual or functional manipulation of the tissue adjacent to the borders in order to duplicate the size and contour of the vestibule resulting in maintains of the peripheral seal during function. This property causes the border molding process to require twenty-four insertions, namely eight in the maxilla and sixteen in the mandible causing long working time and discomfort in patients. Hence, the material used for this technique should provide optimum working time, have adequate body, and permit the correction of border moulding by additions. However additions if made to a single step border moulded material would again introduce all the disadvantages that are associated with sectional moulding Single-step border molding is considerably more straightforward than sectional border molding owing to the reduced number of tray insertions. This technique is usually used with elastomeric impression materials, which may not provide sufficient time to mold and record the peripheral tissues of the denture bearing area. The present technique uses light polymerizing tray material for molding tray borders, offering extended working time. This is advantageous for operators with less experience, such as dental school students. Furthermore, correction of border molding is possible with the addition of new material. The technique uses materials that are readily available,and no special armamentarium is required.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 8, 2022

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 9, 2021

Last Update Submit

March 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retention

    by using a digital force gauge.

    Immediately after Delivery Denture

Study Arms (2)

Retention

EXPERIMENTAL

After Border modeling by traditional and light cure. Amount of force required to dislodge.

Procedure: Border modeling..Measurement

Vestibular depth measurement

EXPERIMENTAL

Casts By using Ney Surveyor

Procedure: Border modeling..Measurement

Interventions

By using light cure to make border modeling in complete denture.

RetentionVestibular depth measurement

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Well-formed edentulous arch (well-rounded, adequate width and height)

You may not qualify if:

  • Patients with undercuts Excessive ridge resorption Flabby anterior ridge Papillary hyperplasia Poor neuromuscular control. Patients having signs of inflammation, ulceration or hyperplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Removable prosthodontic Department -Hama University-Syria

Hama, Syria

Location

Related Publications (5)

  • Pawar RS, Kulkarni RS, Raipure PE. A modified technique for single-step border molding. J Prosthet Dent. 2018 Nov;120(5):654-657. doi: 10.1016/j.prosdent.2017.12.020. Epub 2018 Jul 14.

    PMID: 30017163BACKGROUND
  • Aliotta S. The basics of research. Case Manager. 2003 Jul-Aug;14(4):50-1, 70. doi: 10.1067/mcm.2003.64. No abstract available.

    PMID: 12869949BACKGROUND
  • AlHelal A, AlRumaih HS, Kattadiyil MT, Baba NZ, Goodacre CJ. Comparison of retention between maxillary milled and conventional denture bases: A clinical study. J Prosthet Dent. 2017 Feb;117(2):233-238. doi: 10.1016/j.prosdent.2016.08.007. Epub 2016 Oct 17.

    PMID: 27765399BACKGROUND
  • Rutkunas V, Ignatovic J. A technique to splint and verify the accuracy of implant impression copings with light-polymerizing acrylic resin. J Prosthet Dent. 2014 Mar;111(3):254-6. doi: 10.1016/j.prosdent.2013.08.015. Epub 2014 Jan 17.

    PMID: 24445030BACKGROUND
  • Liang XH, Kim YM, Cho IH. Residual bone height measured by panoramic radiography in older edentulous Korean patients. J Adv Prosthodont. 2014 Feb;6(1):53-9. doi: 10.4047/jap.2014.6.1.53. Epub 2014 Feb 14.

    PMID: 24605207BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 21, 2021

Study Start

September 15, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

March 8, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations