Patient SatisfactionNCT03579134
Satisfaction and Adaptation After Elevation of Vertical Dimension of Occlusion Using Overlay Denture or Fixed Crowns
A study testing partial overlay denture and fixed temporary crowns in people with Patient Satisfaction, run by Cairo University.
Trial summary
Elevation of the vertical dimension of occlusion has always been a debatable issue specially using removable prosthesis. Fixed restorations have been a more predictable treatment modality in treating patients with tooth surface loss. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- partial overlay denture and fixed temporary crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Aug 2018
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients fully dentate or partially edentulous with medium to severe tooth surface loss
- Minimum of one existing occluding pair of posterior teeth on each side (right and left).
- Patients were class 1 skeletal relation Patients requiring elevation 2-5mm.
- Patients having compensated tooth surface loss
Who cannot join
- Patients not having atleast 2 occluding pairs of posterior teeth.
- Skeletal class 2 and 3.
- Edentulous patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Patient Satisfaction and Adaptation After Elevation of Vertical Dimension of Occlusion in Patients With Compensated Tooth Surface Loss Using Partial Overlay Denture or Fixed Temporary Crowns
Elevation of the vertical dimension of occlusion has always been a debatable issue specially using removable prosthesis. Fixed restorations have been a more predictable treatment modality in treating patients with tooth surface loss. A more conservative restoration, more retrievable, and cost effective option is proposed. Partial overlay dentures could provide a reversible and more conservative solution either by being used as a final restoration or teeth are provided with ceramic onlays instead of crowns.
Read the detailed description
Tooth surface loss and its prevalence:
Tooth surface loss is a process that describes loss of hard tooth structure due to reasons other than caries, trauma, or developmental disorders. Lambrechts et al. in 1989 estimated that the physiological tooth surface loss per annum to be approximately between 20-38 micrometers.
More than the average amount of TSL could be described as pathological tooth surface loss. A systematic review of 186 prevalence studies reported an increase of tooth surface loss from 3% at the age of 20 to 17% at the age of 70. Another German study reported similar results.
Pathologic tooth surface loss:
Pathologic tooth surface loss can be classified into attrition, abrasion, erosion, and abfraction.
These factors in addition to overloaded teeth due to partial edentulism can cause loss in the vertical dimension of occlusion (non-compensated by alveolar bone) or loss of tooth substance with dento-alveolar growth preserving the vertical dimension but with unsatisfactory esthetics and sometimes dentine exposure and sensitivity. Vertical dimension of occlusion according to the glossary of prosthodontics is defined as the distance measured between two points when the occluding members are in contact.
Loss of vertical dimension:
Elevation of vertical dimension of occlusion has different modalities. The choice between the treatment options depends mainly on the extent of tooth surface loss (which can be quantified by different classification indices as the popular Smith and Knight classification and the more recent BEWE classification described by Bartlett at 2010), and the aesthetic needs of different patients.
Deciding to go for a restorative treatment can be subdivided into one of three lines which are:
- Altering position of the mandibular closure while maintaining the existing vertical dimension which can only be accomplished in teeth when no need to restore anterior teeth and the rest of the posterior teeth are sound. This concept is based on the different in position between the vertical dimension of occlusion and the centric relation.
- Increasing the vertical dimension of occlusion.
- axial tooth movement through orthodontic treatment of prosthodontic appliances inducing orthodontic forces.
Compensated and non-compensated tooth surface loss:
Tooth surface loss can be either compensated where the freeway space remains within the normal range due to overgrowth of the teeth with the alveolar bone into axial direction, and non-compensated tooth surface loss leading to loss of occlusal vertical dimension and increase in the average freeway space (2-3mm).
Need for esthetic and functional rehabilitation in addition to covering sensitive exposed dentine in both cases urges treatment.
While non-compensated tooth surface loss presents a more predictable and easier modalities of treatment where the freeway space exceeds the average of 2mm, so it is easy to quantify the amount needed to be raised; compensated tooth surface loss based on available studies reported establishment of a new postural position of the mandible and new interocclusal distance obtained even when violating the freeway space.
Based on the previous findings we decided to study alteration of the vertical dimension of occlusion in patients with compensated tooth surface loss.
One group temporized during adaptation period with partial overlay denture and the other using fixed temporary crowns on the new vertical dimension of occlusion. This new vertical dimension is determined according to a wax up where patients included require esthetic alteration between 2-5mm.
Different techniques of alteration of the vertical dimension of occlusion differed between fixed and removable prosthesis through temporization (adaptation period).
Removable prosthesis had the advantage of retrievability, while the fixed ones had the advantage of ensuring patient adherence while symptoms persist.
The investigator's subject groups are fully dentate or partially edentulous patients (free end or long bounded posterior) with at least a pair of occluding posterior teeth on each side. Subjects have moderate to severe tooth surface loss requiring elevation of vertical dimension of occlusion from 2-5mm.
Subjects will be restored using patial overlay denture or fixed temporary crowns.
Partial overlay denture is similar to temporary partial dentures with occlusal extension of teeth where the existing posterior teeth can reach the newly reorganized occlusal plane.
A systematic review conducted in Germany reported symptoms collected from different articles associated with elevation of the vertical dimension of occlusion. These symptoms included headache, tenderness in the masseter and temporalis muscle area upon palpation, clenching, grinding muscle and joint fatigue, soreness of teeth, cheek biting and difficulty in chewing and swallowing.
Studying the two different groups is intended to monitor whether or not these symptoms appear, severity of these symptoms, time taken for alleviation of these symptoms if it does and overall patient satisfaction. Adaptation period will be up to 3 month through which a weekly recall will be done to evaluate adaptation. Patients satisfaction is reported weekly until adaptation occurs or at the end of the time limit using OHIP questionnaire.
Fixed restorations has the benefit of comfort and adherence of the patient over removable options while it might need full crowning with less conservatism and more cost. The partial overlay denture as a removable prosthesis is also less comfortable for the patient but could be proposed as a retrievable, more conservative and a cheaper option.
- Conditions
- Patient Satisfaction
- Being tested
- partial overlay denture, fixed temporary crowns
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial overlay dentureDevice
removable appliance similar to a removable partial denture but with overlay occluslal rests covering the full occlusal surface of the remaining posterior teeth
fixed temporary crownsOther
fixed crowns made from temporary material placed to the newly altered vertical dimension
| Study group | Role | What they receive |
|---|---|---|
| partial overlay denture | Experimental | removable partial denture with a metal extension over the remaining posterior teeth raising their height to the newly proposed vertical dimension and occlusal plane Receives: Device: partial overlay denture |
| fixed temporary crowns | Active comparator | fixed crowns made from temporary material placed on the prepared posterior teeth to the new occlusal plane level elevating the vertical dimension to the newly proposed level Receives: Other: fixed temporary crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of patient satisfaction using OHIP-14 questionnaire
comfort of the patient and satisfaction regarding function, speech, esthetics are assesed using OHIP-14 questionnaire, and assesment will be using a Likert scale. The Likert Scale is a 5 or 7 point scale that offers a range of answer options - from one extreme attitude to another, like "extremely likely" to "not at all likely." Typically, they include a moderate or neutral midpoint.
Measured: 3 months
Secondary outcomes (1)
adaptation
absence of any appearing symptoms associated with elevating the vertical dimension of occlusion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Elkammah, Cairo University
- Investigators
- Amr H Elkammah, B.D.S, Principal investigator, Cairo UniversityAhmed E Fayyad, P.H.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579134
- Sponsor's protocol ID
- amrelkammah
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Abduo J. Safety of increasing vertical dimension of occlusion: a systematic review. Quintessence Int. 2012 May;43(5):369-80.
PubMed 22536588Beddis HP, Durey K, Alhilou A, Chan MF. The restorative management of the deep overbite. Br Dent J. 2014 Nov;217(9):509-15. doi: 10.1038/sj.bdj.2014.953.
PubMed 25377818Davies SJ, Gray RJ, Qualtrough AJ. Management of tooth surface loss. Br Dent J. 2002 Jan 12;192(1):11-6, 19-23. doi: 10.1038/sj.bdj.4801278.
PubMed 11852896Faigenblum M. Removable prostheses. Br Dent J. 1999 Mar 27;186(6):273-6. doi: 10.1038/sj.bdj.4800086.
PubMed 10230101Ibbetson R. Tooth surface loss. 9. Treatment planning. Br Dent J. 1999 Jun 12;186(11):552-8. doi: 10.1038/sj.bdj.4800167. No abstract available.
PubMed 10405470Lambrechts P, Braem M, Vuylsteke-Wauters M, Vanherle G. Quantitative in vivo wear of human enamel. J Dent Res. 1989 Dec;68(12):1752-4. doi: 10.1177/00220345890680120601.
PubMed 2600255Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 2. Active restorative care 1: the management of localised tooth wear. Br Dent J. 2012 Jan 27;212(2):73-82. doi: 10.1038/sj.bdj.2012.48.
PubMed 22281629Carlsson GE, Ingervall B, Kocak G. Effect of increasing vertical dimension on the masticatory system in subjects with natural teeth. J Prosthet Dent. 1979 Mar;41(3):284-9. doi: 10.1016/0022-3913(79)90008-8. No abstract available.
PubMed 283228Gopi Chander N, Venkat R. An appraisal on increasing the occlusal vertical dimension in full occlusal rehabilitation and its outcome. J Indian Prosthodont Soc. 2011 Jun;11(2):77-81. doi: 10.1007/s13191-011-0066-9. Epub 2011 May 27.
PubMed 22654346
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction and Adaptation After Elevation of Vertical Dimension of Occlusion in Patients With Compensated Tooth Surface Loss Using Partial Overlay Denture or Fixed Temporary Crowns
- ClinicalTrials.gov ID
- NCT03579134
- Acronym / sponsor ID
- amrelkammah
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
Elevation of the vertical dimension of occlusion has always been a debatable issue specially using removable prosthesis. Fixed restorations have been a more predictable treatment modality in treating patients with tooth surface loss. A more conservative restoration, more retrievable, and cost effective option is proposed. Partial overlay dentures could provide a reversible and more conservative solution either by being used as a final restoration or teeth are provided with ceramic onlays instead of crowns.
Detailed description
Tooth surface loss and its prevalence:
Tooth surface loss is a process that describes loss of hard tooth structure due to reasons other than caries, trauma, or developmental disorders. Lambrechts et al. in 1989 estimated that the physiological tooth surface loss per annum to be approximately between 20-38 micrometers.
More than the average amount of TSL could be described as pathological tooth surface loss. A systematic review of 186 prevalence studies reported an increase of tooth surface loss from 3% at the age of 20 to 17% at the age of 70. Another German study reported similar results.
Pathologic tooth surface loss:
Pathologic tooth surface loss can be classified into attrition, abrasion, erosion, and abfraction.
These factors in addition to overloaded teeth due to partial edentulism can cause loss in the vertical dimension of occlusion (non-compensated by alveolar bone) or loss of tooth substance with dento-alveolar growth preserving the vertical dimension but with unsatisfactory esthetics and sometimes dentine exposure and sensitivity. Vertical dimension of occlusion according to the glossary of prosthodontics is defined as the distance measured between two points when the occluding members are in contact.
Loss of vertical dimension:
Elevation of vertical dimension of occlusion has different modalities. The choice between the treatment options depends mainly on the extent of tooth surface loss (which can be quantified by different classification indices as the popular Smith and Knight classification and the more recent BEWE classification described by Bartlett at 2010), and the aesthetic needs of different patients.
Deciding to go for a restorative treatment can be subdivided into one of three lines which are:
- Altering position of the mandibular closure while maintaining the existing vertical dimension which can only be accomplished in teeth when no need to restore anterior teeth and the rest of the posterior teeth are sound. This concept is based on the different in position between the vertical dimension of occlusion and the centric relation.
- Increasing the vertical dimension of occlusion.
- axial tooth movement through orthodontic treatment of prosthodontic appliances inducing orthodontic forces.
Compensated and non-compensated tooth surface loss:
Tooth surface loss can be either compensated where the freeway space remains within the normal range due to overgrowth of the teeth with the alveolar bone into axial direction, and non-compensated tooth surface loss leading to loss of occlusal vertical dimension and increase in the average freeway space (2-3mm).
Need for esthetic and functional rehabilitation in addition to covering sensitive exposed dentine in both cases urges treatment.
While non-compensated tooth surface loss presents a more predictable and easier modalities of treatment where the freeway space exceeds the average of 2mm, so it is easy to quantify the amount needed to be raised; compensated tooth surface loss based on available studies reported establishment of a new postural position of the mandible and new interocclusal distance obtained even when violating the freeway space.
Based on the previous findings we decided to study alteration of the vertical dimension of occlusion in patients with compensated tooth surface loss.
One group temporized during adaptation period with partial overlay denture and the other using fixed temporary crowns on the new vertical dimension of occlusion. This new vertical dimension is determined according to a wax up where patients included require esthetic alteration between 2-5mm.
Different techniques of alteration of the vertical dimension of occlusion differed between fixed and removable prosthesis through temporization (adaptation period).
Removable prosthesis had the advantage of retrievability, while the fixed ones had the advantage of ensuring patient adherence while symptoms persist.
The investigator's subject groups are fully dentate or partially edentulous patients (free end or long bounded posterior) with at least a pair of occluding posterior teeth on each side. Subjects have moderate to severe tooth surface loss requiring elevation of vertical dimension of occlusion from 2-5mm.
Subjects will be restored using patial overlay denture or fixed temporary crowns.
Partial overlay denture is similar to temporary partial dentures with occlusal extension of teeth where the existing posterior teeth can reach the newly reorganized occlusal plane.
A systematic review conducted in Germany reported symptoms collected from different articles associated with elevation of the vertical dimension of occlusion. These symptoms included headache, tenderness in the masseter and temporalis muscle area upon palpation, clenching, grinding muscle and joint fatigue, soreness of teeth, cheek biting and difficulty in chewing and swallowing.
Studying the two different groups is intended to monitor whether or not these symptoms appear, severity of these symptoms, time taken for alleviation of these symptoms if it does and overall patient satisfaction. Adaptation period will be up to 3 month through which a weekly recall will be done to evaluate adaptation. Patients satisfaction is reported weekly until adaptation occurs or at the end of the time limit using OHIP questionnaire.
Fixed restorations has the benefit of comfort and adherence of the patient over removable options while it might need full crowning with less conservatism and more cost. The partial overlay denture as a removable prosthesis is also less comfortable for the patient but could be proposed as a retrievable, more conservative and a cheaper option.
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 |
|---|---|---|
| partial overlay denture | Experimental | Device: partial overlay dentureremovable partial denture with a metal extension over the remaining posterior teeth raising their height to the newly proposed vertical dimension and occlusal plane |
| fixed temporary crowns | Active comparator | Other: fixed temporary crownsfixed crowns made from temporary material placed on the prepared posterior teeth to the new occlusal plane level elevating the vertical dimension to the newly proposed level |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients fully dentate or partially edentulous with medium to severe tooth surface loss
- Minimum of one existing occluding pair of posterior teeth on each side (right and left).
- Patients were class 1 skeletal relation Patients requiring elevation 2-5mm.
- Patients having compensated tooth surface loss
Key exclusion criteria (3 listed)
- Patients not having atleast 2 occluding pairs of posterior teeth.
- Skeletal class 2 and 3.
- Edentulous patients
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 |
|---|---|---|
| partial overlay dentureremovable appliance similar to a removable partial denture but with overlay occluslal rests covering the full occlusal surface of the remaining posterior teeth | Device | partial overlay denture |
| fixed temporary crownsfixed crowns made from temporary material placed to the newly altered vertical dimension | Other | fixed temporary crowns |
Primary outcome
Assesment of patient satisfaction using OHIP-14 questionnaire
Time frame: 3 months
comfort of the patient and satisfaction regarding function, speech, esthetics are assesed using OHIP-14 questionnaire, and assesment will be using a Likert scale. The Likert Scale is a 5 or 7 point scale that offers a range of answer options - from one extreme attitude to another, like "extremely likely" to "not at all likely." Typically, they include a moderate or neutral midpoint.
1 secondary outcome
adaptation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 22536588Abduo J. Safety of increasing vertical dimension of occlusion: a systematic review. Quintessence Int. 2012 May;43(5):369-80.
- Background: PubMed 25377818Beddis HP, Durey K, Alhilou A, Chan MF. The restorative management of the deep overbite. Br Dent J. 2014 Nov;217(9):509-15. doi: 10.1038/sj.bdj.2014.953.
- Background: PubMed 11852896Davies SJ, Gray RJ, Qualtrough AJ. Management of tooth surface loss. Br Dent J. 2002 Jan 12;192(1):11-6, 19-23. doi: 10.1038/sj.bdj.4801278.
- Background: PubMed 10230101Faigenblum M. Removable prostheses. Br Dent J. 1999 Mar 27;186(6):273-6. doi: 10.1038/sj.bdj.4800086.
- Background: PubMed 10405470Ibbetson R. Tooth surface loss. 9. Treatment planning. Br Dent J. 1999 Jun 12;186(11):552-8. doi: 10.1038/sj.bdj.4800167. No abstract available.
- Background: PubMed 2600255Lambrechts P, Braem M, Vuylsteke-Wauters M, Vanherle G. Quantitative in vivo wear of human enamel. J Dent Res. 1989 Dec;68(12):1752-4. doi: 10.1177/00220345890680120601.
- Background: PubMed 22281629Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 2. Active restorative care 1: the management of localised tooth wear. Br Dent J. 2012 Jan 27;212(2):73-82. doi: 10.1038/sj.bdj.2012.48.
- Background: PubMed 283228Carlsson GE, Ingervall B, Kocak G. Effect of increasing vertical dimension on the masticatory system in subjects with natural teeth. J Prosthet Dent. 1979 Mar;41(3):284-9. doi: 10.1016/0022-3913(79)90008-8. No abstract available.
- Background: PubMed 22654346Gopi Chander N, Venkat R. An appraisal on increasing the occlusal vertical dimension in full occlusal rehabilitation and its outcome. J Indian Prosthodont Soc. 2011 Jun;11(2):77-81. doi: 10.1007/s13191-011-0066-9. Epub 2011 May 27.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Amr H Elkammah, B.D.S principal investigator
Cairo University
Ahmed E Fayyad, P.H.D study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing partial overlay denture and fixed temporary crowns in people with Patient Satisfaction, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr H Elkammah, B.D.S (01001688382 ext. +2, amr-hassan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of patient satisfaction using OHIP-14 questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579134, which also lists 9 linked publications.
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 6 Jul 2018.