Trial Outcomes & Findings for Caries Prevention Effect of S-PRG Filler Incorporated in Denture Base Resins on Edentulous Elderly People (NCT NCT02460562)

Results Overview

Whole mixed saliva was collected by passive drooling into individual plastic vials to a volume of 2 ml while wearing the denture to determine the capacity for fluoride release and recharge from the denture. Saliva fluoride concentrations (ppm) were assessed at multiple time points (baseline, days 1, 14, 15, and 3 months and 1.5 years) to compare with baseline concentration under the conditions that the participants wear the resin denture at least 1 hour and refrain from tooth brushing at least 2 hours before saliva sampling. The salivary fluoride content (ppm) of each solution was determined using a fluoride ion electrode (item number 27502-19, Cole-Palmer, USA) connected to a 710 A plus fluoride ion meter (item number 067952, Thermo Orion, USA).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

on days 1, 14, 15, and 3 months and 1.5 years of wearing the denture

Results posted on

2019-06-03

Participant Flow

Recruitment of subjects was carried out through hospital media from three government hospitals; Krathum Baen Hospital, Samut Sakhon Province, Health Promotion Center Region 1, Bangkok and Thammasat University Hospital, Pathum Thani Province. Subjects who were interested in the study could register directly at the dental clinic.

Subjects who registered for a screening appointment at the dental clinic were asked to complete a questionnaire and underwent an oral screening and a simple test of salivary flow rate at the screening visit. The subjects who met eligibility criteria were asked whether or not they would agree to participate in the study.

Participant milestones

Participant milestones
Measure	PMMA Resin A denture base was made with PMMA resin as a standard material. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.	PMMA Resin & S-PRG Filler A denture base was made from PMMA resin containing S-PRG fillers for subject to wear. Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention. The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that inc
Overall Study STARTED	74	76
Overall Study COMPLETED	59	60
Overall Study NOT COMPLETED	15	16

Reasons for withdrawal

Reasons for withdrawal
Measure	PMMA Resin A denture base was made with PMMA resin as a standard material. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.	PMMA Resin & S-PRG Filler A denture base was made from PMMA resin containing S-PRG fillers for subject to wear. Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention. The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that inc
Overall Study Lost to Follow-up	15	16

Baseline Characteristics

Caries Prevention Effect of S-PRG Filler Incorporated in Denture Base Resins on Edentulous Elderly People

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PMMA Resin n=74 Participants A denture base was made with PMMA resin as a standard material. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.	PMMA Resin & S-PRG Filler n=76 Participants A denture base was made from PMMA resin containing S-PRG fillers for subject to wear. Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention. The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that inc	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=5 Participants	76 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.31 years STANDARD_DEVIATION 10.81 • n=5 Participants	47.66 years STANDARD_DEVIATION 10.58 • n=7 Participants	47.98 years STANDARD_DEVIATION 10.66 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Thailand	74 participants n=5 Participants	76 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: on days 1, 14, 15, and 3 months and 1.5 years of wearing the denture

Population: A total of 150 Thai adults aged 35-60 years, were initially enrolled in this study. At a baseline visit, 31 males (20.7%) and 119 females (79.3%) with a mean age of 48.9 ± 10.6 years fulfilled the study inclusion criteria and participated in this study. Approximately eighty percent (119/150) of the study adults were followed over 1.5 years.

Whole mixed saliva was collected by passive drooling into individual plastic vials to a volume of 2 ml while wearing the denture to determine the capacity for fluoride release and recharge from the denture. Saliva fluoride concentrations (ppm) were assessed at multiple time points (baseline, days 1, 14, 15, and 3 months and 1.5 years) to compare with baseline concentration under the conditions that the participants wear the resin denture at least 1 hour and refrain from tooth brushing at least 2 hours before saliva sampling. The salivary fluoride content (ppm) of each solution was determined using a fluoride ion electrode (item number 27502-19, Cole-Palmer, USA) connected to a 710 A plus fluoride ion meter (item number 067952, Thermo Orion, USA).

Outcome measures

Outcome measures
Measure	PMMA Resin n=74 Participants A denture base was made with PMMA resin as a standard material. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.	PMMA Resin & S-PRG Filler n=76 Participants A denture base was made from PMMA resin containing S-PRG fillers. Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions including fluoride to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention. The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567.
Saliva Fluoride Concentration (Part Per Million,Ppm) Baseline	0.05 part per million,ppm Standard Deviation 0.04	0.05 part per million,ppm Standard Deviation 0.05
Saliva Fluoride Concentration (Part Per Million,Ppm) Day 1	0.09 part per million,ppm Standard Deviation 0.07	0.22 part per million,ppm Standard Deviation 0.12
Saliva Fluoride Concentration (Part Per Million,Ppm) Day 14	0.06 part per million,ppm Standard Deviation 0.06	0.06 part per million,ppm Standard Deviation 0.05
Saliva Fluoride Concentration (Part Per Million,Ppm) Day 15	0.11 part per million,ppm Standard Deviation 0.11	0.23 part per million,ppm Standard Deviation 0.13
Saliva Fluoride Concentration (Part Per Million,Ppm) 3 months	0.12 part per million,ppm Standard Deviation 0.12	0.26 part per million,ppm Standard Deviation 0.15
Saliva Fluoride Concentration (Part Per Million,Ppm) 1.5 Years	0.08 part per million,ppm Standard Deviation 0.12	0.32 part per million,ppm Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline and 1.5 years of follow up

Population: The transition (∆Q) of surface number, n (%) of developed new caries from baseline to 1.5 years of follow up was determined as progression or arrested rate.

Caries record per surface using ICDAS coding system were determined at baseline and at 1.5 years of follow-up

Outcome measures

Outcome measures
Measure	PMMA Resin n=3523 Caries examined (number of surface) A denture base was made with PMMA resin as a standard material. PMMA resin: Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.	PMMA Resin & S-PRG Filler n=3479 Caries examined (number of surface) A denture base was made from PMMA resin containing S-PRG fillers. Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions including fluoride to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention. The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567.
Assessment of Enamel Caries Arrest	3353 Caries examined (number of surface)	3402 Caries examined (number of surface)
Assessment of Enamel Caries Progress	170 Caries examined (number of surface)	77 Caries examined (number of surface)

Adverse Events

PMMA Resin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PMMA Resin & S-PRG Filler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kritirat Kiatsirirote

Faculty of Dentistry, Thammasat University

Phone: 662-9869213-5

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place