Edentulous MouthNCT01230320
Simplified vs. Conventional Methods for Complete Denture Fabrication
A study testing Denture fabrication technique in people with Edentulous Mouth and Edentulous Jaw, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex technical procedures. Those procedures include two impressions for each jaw, the registration of the relationship between the upper teeth and the patient's head and usually two appointments for tooth try-in. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Edentulous Mouth, Edentulous Jaw
- What is being tested?
- Denture fabrication technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous for at least 1 year
- Patients requesting new maxillary and mandibular complete dentures
- Mental receptiveness
- Good understanding of spoken Portuguese
Who cannot join
- Debilitating systemic diseases
- Pathologic changes of residual edentulous ridges
- Dysfunctional disorders of the masticatory system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplified vs. Conventional Methods for the Fabrication of Complete Dentures in a Public Health Setting
BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex technical procedures. Those procedures include two impressions for each jaw, the registration of the relationship between the upper teeth and the patient's head and usually two appointments for tooth try-in. However, recent studies have questioned the real need for such complex procedures. Simplified methods could have similar results if compared with conventional ones, and dentures would be delivered faster and with lower costs.
OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a simplified or conventional method.
METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão Preto Dental School will be randomly divided into two groups. Group S will receive new dentures fabricated by a simplified method, whereas Group C will received new dentures according to a conventional method. Participants will complete a questionnaire for denture satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At the same time, a specialist in dental prostheses will evaluate the quality of new dentures.
Read the detailed description
Complete edentulism can be considered as an important public health problem, particularly in the elderly. The prevalence of edentulism among adults aged 65 or more years is still high in several countries, such as Canada (58%), Saudi Arabia (31-46%), United Kingdom (46%), China (11%) and India (19%). Normative needs of maxillary and mandibular complete dentures in Brazilian elders were estimated to be 16% and 24%, respectively. This way, the epidemiologic aspect reinforces the need for cost-effective methods when treating patients with complete dentures.
The conventional methods for fabrication of complete dentures demand a comprehensive sequence of clinical and laboratorial procedures. Those methods seem to be accepted and taught by most of the American and Brazilian dental schools. However, it has been argued whether they are necessary for the obtainment of adequate dentures. Several approaches were described in attempt to simplify clinical and laboratorial stages, i.e. the fabrication of denture bases directly on casts obtained from irreversible hydrocolloid impressions made in stock trays. Other simplified approaches include the fabrication without facebow transfer, alternative occlusal schemes (i.e. lingualized occlusion) and duplication techniques.
A few recent randomized clinical trials have provided some high level evidence about the efficacy of simplified methods. We ran the following search strategy for PubMed at October 2010:
(overdenture or ((removable or complete) and denture)) and ((techni* or fabricat* or simpl* or tradition*) or (impression* or occlus* or (facebow or face-bow) or remount* or adjust*)) and (((randomized controlled trial [pt]) OR (controlled clinical trial [pt]) OR (randomized [tiab]) OR (placebo [tiab]) OR (drug therapy [sh]) OR (randomly [tiab]) OR (trial [tiab]) OR (groups [tiab])) AND (humans [mh]))
After reading the 470 titles and abstracts, and examining possible reports of randomized clinical trials, only two studies that attempted to evaluate simplified methods for denture fabrication were found.
One of the studies compared a simplified and a conventional method for complete denture fabrication by a parallel arms trial. The difference between the methods was the use of a second impression, facebow transfer and remount by the conventional approach. No significant difference between the groups was found for the outcome variables tested - denture quality and patient satisfaction. The other trial compared the relative efficacy of complete dentures fabricated according to two occlusal concepts, by means of a crossover design. A more complex method employed a facebow transfer with recordings of condylar inclination, gothic arch tracing and bilateral balanced occlusion. The simplified technique used no facebow transfer, manual technique for the record of centric occlusion and canine guidance. Denture satisfaction was not influenced by the fabrication method.
The current evidence raises doubt about the relevance of some procedures involved in the fabrication of complete dentures. Despite the high quality of the previously cited trials, further studies could use a more pragmatically approach such as testing methods in public health patients. Moreover, data from additional studies could be summarized in the future by means of meta-analysis and thus evidence would be stronger. In summary, such studies may provide support to either:
- Improve access of the edentulous patients to complete denture treatment by lowering costs and complexity;
- Reinforce the importance of technical procedures during denture fabrication.
OBJECTIVES
To compare complete dentures fabricated with a simplified technique and conventional prostheses for the rehabilitation of edentulous patients, after 3 and 6 months of wearing.
The null hypothesis will be that mean values of oral health-related quality of life for pairs of dentures fabricated by the simplified and the conventional dentures are similar. Similar secondary hypotheses will be considered for the secondary variables.
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Being tested
- Denture fabrication technique
- Keywords
- Cost estimates, Complete Denture, Dental Economics, Dental Impression Technique, Denture Retention, Edentulous, Edentulism, Oral Health-Related Quality of Life, Patient Acceptance of Health Care, Patient Satisfaction, Quality of Health Care, Quality of Life
- Medical subject headings
- Mouth, Edentulous, Jaw, Edentulous, Patient Acceptance of Health Care, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture fabrication techniqueProcedure or surgery
Also called - Fabrication of complete dentures;, - Complete denture fabrication technique.
Sequence of procedures involved with the fabrication of conventional complete dentures. Examples of common procedures are:
- the reproduction of denture-bearing tissues by means of impression techniques and casts;
- the registration of maxillo-mandibular relations;
- try-in of artificial teeth and carved denture bases.
| Study group | Role | What they receive |
|---|---|---|
| Simplified (S) technique | Experimental | Complete dentures fabricated according to a simplified technique, divided into the following four sessions:
1. Maxillary and mandibular casts will be obtained from irreversible hydrocolloid impressions made in stock trays.
2. Record bases will be adjusted according to vertical dimension and centric relation measurements, without facebow transfer. Casts will be mounted in a semi-adjustable articulator using standardized measures and artificial teeth will be selected.
3. Trial dentures will be evaluated for esthetics and maxillomandibular relationships.
4. Insertion of finished dentures. Receives: Procedure: Denture fabrication technique |
| Conventional (C) technique | Active comparator | Complete dentures fabricated according to a conventional technique:
1. Initial impression and the obtainment of custom trays;
2. Final impression with border molding using compound;
3. Facebow transfer;
4. Determination of maxillomandibular relationship;
5. Try-in of anterior teeth;
6. Try-in of posterior teeth;
7. Insertion of finished dentures. Receives: Procedure: Denture fabrication technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Measured: 6 months
Secondary outcomes (4)
Denture satisfaction
To be assessed by specific questionnaires.
Measured: 6 months
Denture quality
To be assessed by means of clinical exam following a specific form.
Measured: 3 months
Post-insertion adjustments
Necessary post-insertion, as done routinely for conventional denture patients.
Measured: 14 days
Treatment costs
This outcome will be measured by means of specific forms, according to 2 components:
- Direct costs: cost of labor, materials, radiographs and medications;
- Indirect costs: patient's time and transportation expenses.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Raphael Freitas de Souza, University of Sao Paulo
- Investigators
- Raphael F de Souza, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230320
- Sponsor's protocol ID
- FORP-PT-001
- Other IDs
- 2010.1.971.58.0, 2010/09381-9
- Status last verified
- Aug 2016
- First submitted
- 27 Oct 2010
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified vs. Conventional Methods for the Fabrication of Complete Dentures in a Public Health Setting
- ClinicalTrials.gov ID
- NCT01230320
- Acronym / sponsor ID
- FORP-PT-001
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Keywords
- Cost estimates, Complete Denture, Dental Economics, Dental Impression Technique, Denture Retention, Edentulous, Edentulism, Oral Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex technical procedures. Those procedures include two impressions for each jaw, the registration of the relationship between the upper teeth and the patient's head and usually two appointments for tooth try-in. However, recent studies have questioned the real need for such complex procedures. Simplified methods could have similar results if compared with conventional ones, and dentures would be delivered faster and with lower costs.
OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a simplified or conventional method.
METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão Preto Dental School will be randomly divided into two groups. Group S will receive new dentures fabricated by a simplified method, whereas Group C will received new dentures according to a conventional method. Participants will complete a questionnaire for denture satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At the same time, a specialist in dental prostheses will evaluate the quality of new dentures.
Detailed description
Complete edentulism can be considered as an important public health problem, particularly in the elderly. The prevalence of edentulism among adults aged 65 or more years is still high in several countries, such as Canada (58%), Saudi Arabia (31-46%), United Kingdom (46%), China (11%) and India (19%). Normative needs of maxillary and mandibular complete dentures in Brazilian elders were estimated to be 16% and 24%, respectively. This way, the epidemiologic aspect reinforces the need for cost-effective methods when treating patients with complete dentures.
The conventional methods for fabrication of complete dentures demand a comprehensive sequence of clinical and laboratorial procedures. Those methods seem to be accepted and taught by most of the American and Brazilian dental schools. However, it has been argued whether they are necessary for the obtainment of adequate dentures. Several approaches were described in attempt to simplify clinical and laboratorial stages, i.e. the fabrication of denture bases directly on casts obtained from irreversible hydrocolloid impressions made in stock trays. Other simplified approaches include the fabrication without facebow transfer, alternative occlusal schemes (i.e. lingualized occlusion) and duplication techniques.
A few recent randomized clinical trials have provided some high level evidence about the efficacy of simplified methods. We ran the following search strategy for PubMed at October 2010:
(overdenture or ((removable or complete) and denture)) and ((techni* or fabricat* or simpl* or tradition*) or (impression* or occlus* or (facebow or face-bow) or remount* or adjust*)) and (((randomized controlled trial [pt]) OR (controlled clinical trial [pt]) OR (randomized [tiab]) OR (placebo [tiab]) OR (drug therapy [sh]) OR (randomly [tiab]) OR (trial [tiab]) OR (groups [tiab])) AND (humans [mh]))
After reading the 470 titles and abstracts, and examining possible reports of randomized clinical trials, only two studies that attempted to evaluate simplified methods for denture fabrication were found.
One of the studies compared a simplified and a conventional method for complete denture fabrication by a parallel arms trial. The difference between the methods was the use of a second impression, facebow transfer and remount by the conventional approach. No significant difference between the groups was found for the outcome variables tested - denture quality and patient satisfaction. The other trial compared the relative efficacy of complete dentures fabricated according to two occlusal concepts, by means of a crossover design. A more complex method employed a facebow transfer with recordings of condylar inclination, gothic arch tracing and bilateral balanced occlusion. The simplified technique used no facebow transfer, manual technique for the record of centric occlusion and canine guidance. Denture satisfaction was not influenced by the fabrication method.
The current evidence raises doubt about the relevance of some procedures involved in the fabrication of complete dentures. Despite the high quality of the previously cited trials, further studies could use a more pragmatically approach such as testing methods in public health patients. Moreover, data from additional studies could be summarized in the future by means of meta-analysis and thus evidence would be stronger. In summary, such studies may provide support to either:
- Improve access of the edentulous patients to complete denture treatment by lowering costs and complexity;
- Reinforce the importance of technical procedures during denture fabrication.
OBJECTIVES
To compare complete dentures fabricated with a simplified technique and conventional prostheses for the rehabilitation of edentulous patients, after 3 and 6 months of wearing.
The null hypothesis will be that mean values of oral health-related quality of life for pairs of dentures fabricated by the simplified and the conventional dentures are similar. Similar secondary hypotheses will be considered for the secondary variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified (S) technique | Experimental | Procedure: Denture fabrication techniqueComplete dentures fabricated according to a simplified technique, divided into the following four sessions: 1. Maxillary and mandibular casts will be obtained from irreversible hydrocolloid impressions made in stock trays. 2. Record bases will be adjusted according to vertical dimension and centric relation measurements, without facebow transfer. Casts will be mounted in a semi-adjustable articulator using standardized measures and artificial teeth will be selected. 3. Trial dentures will be evaluated for esthetics and maxillomandibular relationships. 4. Insertion of finished dentures. |
| Conventional (C) technique | Active comparator | Procedure: Denture fabrication techniqueComplete dentures fabricated according to a conventional technique: 1. Initial impression and the obtainment of custom trays; 2. Final impression with border molding using compound; 3. Facebow transfer; 4. Determination of maxillomandibular relationship; 5. Try-in of anterior teeth; 6. Try-in of posterior teeth; 7. Insertion of finished dentures. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completely edentulous for at least 1 year
- Patients requesting new maxillary and mandibular complete dentures
- Mental receptiveness
- Good understanding of spoken Portuguese
Key exclusion criteria (3 listed)
- Debilitating systemic diseases
- Pathologic changes of residual edentulous ridges
- Dysfunctional disorders of the masticatory system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denture fabrication techniqueAlso: - Fabrication of complete dentures;, - Complete denture fabrication technique.Sequence of procedures involved with the fabrication of conventional complete dentures. Examples of common procedures are: 1. the reproduction of denture-bearing tissues by means of impression techniques and casts; 2. the registration of maxillo-mandibular relations; 3. try-in of artificial teeth and carved denture bases. | Procedure or surgery | Conventional (C) technique, Simplified (S) technique |
Primary outcome
Oral health-related quality of life
Time frame: 6 months
To be assessed by means of the Brazilian version of the OHIP-EDENT.
4 secondary outcomes
Denture satisfaction
Time frame: 6 months
Denture quality
Time frame: 3 months
Post-insertion adjustments
Time frame: 14 days
Treatment costs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Institutional page of the Ribeirão Preto Dental School (research site)Link provided by the sponsor.
- Principal Investigator´s CVLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael F de Souza, DDS, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denture fabrication technique in people with Edentulous Mouth and Edentulous Jaw, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health-related quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.