## Protocol Section
### Identification Module
**NCT ID:** NCT02203279

**Brief Title:** Evaluation of Three Hard Relining Materials in Complete Dentures

**Official Title:** Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study

#### Organization Study ID Info
**ID:** UDDS-RemPro-02-2014
#### Organization
**Class:** OTHER
**Full Name:** Damascus University
### Status Module
#### Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-08

**Type:** ACTUAL

#### Start Date
**Date:** 2014-07

**Status Verified Date:** 2015-09

#### Study First Post Date
**Date:** 2014-07-29
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-28
**Study First Submit QC Date:** 2014-07-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Damascus University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and 6 months of use with mandibular complete dentures. The effect of hard relining materials on supporting tissues and patients' satisfaction will also be assessed.

Materials and Methods: 36 complete edentulous patients who already have maxillary dentures and complaining of instable mandibular dentures will be invited to participate in this study. Mandibular dentures will be relined randomly by one of three relining materials: two chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology Co, Holland).

The color stability of relining material, peeling, and the effect on supporting tissue will be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition, patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS) ranging from 0 to 100.

**Detailed Description:** Relining denture is a process of resurfacing the tissue side of a denture to make it fit more accurately Direct relining of removable dentures with hard chair-side reline materials is suitable for improving the fit of the denture bases to the supporting tissues. Chairside reline materials are more convenient than those processed in a laboratory because the direct method is faster and does not cause clinically significant dimensional changes of the reline resin. However, when autopolymerized reline resins are used with a direct method, several problems can occur as burning sensation caused by monomers, an exothermic heat reaction and an unpleasant odor.

There are three types of hard relining chair-side materials: Dual-polymerized Visible light-polymerized as Triad DuaLine, Light Liner (Hard), Astron LC (Hard).Visible light-polymerized as Lightdon-U, Triad Hi-Flow Reline Material, Triad VLC Reline Material. Finally, autopolymerized as New Truline, Tokuyama Rebase II (Fast) , GC Reline. Other concerns related to direct reline materials include patient tolerance (taste, temperature, odor), color stability, durability and ease of handling and polishing.

Few studies evaluated the effect of disinfection solutions on relining materials properties as roughness and hardness. In one study, disinfectant solutions caused a decrease in hardness, whereas with roughness, the materials tested showed a statistically significant increase, except for Tokuyama. Depending on the examined relining materials, some materials have increased and the others have decreased surface roughness after immersion in disinfecting solutions or microwave disinfection.

All previous laboratory studies concentrated on the effects of disinfection on relining materials properties as roughness, hardness, color change. However, the clinical studies did not compare chemically cured and heat cured relining materials and their effects on supporting tissue. The aim of this study is to evaluate the clinical performance of two -chemically cured- and heat cured denture relining material after 3 and 6 months of use. In addition, the effect of hard relining materials on supporting tissues, and patients' satisfaction has not been evaluated yet.

### Conditions Module

**Conditions:**

- Complete Mandibular Dentures With Poor Retention

**Keywords:**

- Chair-side hard relining

- complete denture

- patients' satisfaction

- supporting tissues

- autopolymerized reline resins

- heat cured relining material

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The direct chair-side relining materiel 'Rebase II Fast' will be used.

**Intervention Names:**

- Other: Rebase II Fast

**Label:** Rebase II Fast

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The direct chair-side relining material Flexacryl will be used

**Intervention Names:**

- Other: Flexacryl

**Label:** Flexacryl

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Vertex is a heat-cured resin material which is going to be used for indirect relining

**Intervention Names:**

- Other: Vertex

**Label:** Vertex

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rebase II Fast

**Description:** It is going to be used a direct relining material

**Name:** Rebase II Fast

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Flexacryl

**Description:** This is going to be used as a second direct relining material

**Name:** Flexacryl

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Vertex

**Description:** This is going to be used as an indirect relining material

**Name:** Vertex

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:

Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.

Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.

Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.

Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.

**Measure:** Supporting Alveolar Mucosa Status_3

**Time Frame:** This will be measured at three months following relining

**Description:** According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:

Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.

Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.

Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.

Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.

**Measure:** Supporting Alveolar Mucosa Status_6

**Time Frame:** This variable will be assessed at six months following relining

**Description:** The color stability variable has four degrees on clinical examination:

1. no change
2. simple
3. medium
4. large

**Measure:** Color Stability_3

**Time Frame:** This will be assessed at three moths following relining

#### Secondary Outcomes

**Description:** The color stability variable has four degrees on clinical examination:

no change simple medium large

**Measure:** Color Stability_6

**Time Frame:** This be assessed at six months following relining

**Description:** This variable is going to be inspected clinically and it has two categories:

1. peeling more than 4 mm
2. peeling less than 4 mm

**Measure:** Peeling_3

**Time Frame:** This variable is going to be assessed at three months following relining

**Description:** This variable is going to be inspected clinically and it has two categories:

1. peeling more than 4 mm
2. peeling less than 4 mm

**Measure:** Peeling_6

**Time Frame:** This variable is going to be assessed at six months following relining

**Description:** Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.

**Measure:** Satisfaction_3

**Time Frame:** This is going to be measured at three months following relining

**Description:** Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.

**Measure:** Satisfaction_6

**Time Frame:** This is going to be measured at six months following relining

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age between 45-80 year,
* complete maxillary and lower dentures
* Mandibular dentures with poor retention

Exclusion Criteria:

* Patients with good stability of mandibular dentures.
* Partial maxillary edentulous patients

**Maximum Age:** 78 Years

**Minimum Age:** 47 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Damascus

**Country:** Syrian Arab Republic

**Facility:** Department of Removable Prosthodontics, University of Damascus Dental School

**Zip:** DM20AM18

#### Overall Officials

**Official 1:**

**Affiliation:** PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus

**Name:** Omar Teriaky, DDS MSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Associate Professor, Removable Prosthodontics Department, University of Damascus Dental School, Damascus

**Name:** Muhannad Alssadi, DDS MSc PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Al Rifaiy MQ. Shear bond strength between light polymerized hard reline resin and denture base resin subjected to long term water immersion. Saudi Dent J. 2012 Jan;24(1):23-7. doi: 10.1016/j.sdentj.2011.10.004. Epub 2011 Nov 20.

**PMID:** 23960524

**Citation:** Arima T, Murata H, Hamada T. Analysis of composition and structure of hard autopolymerizing reline resins. J Oral Rehabil. 1996 May;23(5):346-52. doi: 10.1111/j.1365-2842.1996.tb00863.x.

**PMID:** 8736448

**Citation:** Pinto Lde R, Acosta EJ, Tavora FF, da Silva PM, Porto VC. Effect of repeated cycles of chemical disinfection on the roughness and hardness of hard reline acrylic resins. Gerodontology. 2010 Jun;27(2):147-53. doi: 10.1111/j.1741-2358.2009.00282.x. Epub 2009 Jun 8.

**PMID:** 19508322

**Citation:** Haywood J, Basker RM, Watson CJ, Wood DJ. A comparison of three hard chairside denture reline materials. Part I. Clinical evaluation. Eur J Prosthodont Restor Dent. 2003 Dec;11(4):157-63.

**PMID:** 14737792

**Citation:** Hong G, Murata H, Li Y, Sadamori S, Hamada T. Influence of denture cleansers on the color stability of three types of denture base acrylic resin. J Prosthet Dent. 2009 Mar;101(3):205-13. doi: 10.1016/S0022-3913(09)60032-9.

**PMID:** 19231574

**Citation:** Machado AL, Breeding LC, Vergani CE, da Cruz Perez LE. Hardness and surface roughness of reline and denture base acrylic resins after repeated disinfection procedures. J Prosthet Dent. 2009 Aug;102(2):115-22. doi: 10.1016/S0022-3913(09)60120-7.

**PMID:** 19643225

**Citation:** Machado AL, Giampaolo ET, Vergani CE, Souza JF, Jorge JH. Changes in roughness of denture base and reline materials by chemical disinfection or microwave irradiation: surface roughness of denture base and reline materials. J Appl Oral Sci. 2011 Oct;19(5):521-8. doi: 10.1590/s1678-77572011000500015.

**PMID:** 21986658

**Citation:** Matsumura H, Tanoue N, Kawasaki K, Atsuta M. Clinical evaluation of a chemically cured hard denture relining material. J Oral Rehabil. 2001 Jul;28(7):640-4. doi: 10.1046/j.1365-2842.2001.00701.x.

**PMID:** 11422696

**Citation:** Murata H, Seo RS, Hamada T, Polyzois GL, Frangou MJ. Dynamic mechanical properties of hard, direct denture reline resins. J Prosthet Dent. 2007 Oct;98(4):319-26. doi: 10.1016/S0022-3913(07)60105-X.

**PMID:** 17936130

**Citation:** Ogle RE, Sorensen SE, Lewis EA. A new visible light-cured resin system applied to removable prosthodontics. J Prosthet Dent. 1986 Oct;56(4):497-506. doi: 10.1016/0022-3913(86)90397-5.

**PMID:** 3463760

**Citation:** Wyatt CC, Harrop TJ, MacEntee MI. A comparison of physical characteristics of six hard denture reline materials. J Prosthet Dent. 1986 Mar;55(3):343-6. doi: 10.1016/0022-3913(86)90117-4.

**PMID:** 3457166

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
