Premature Loss of Primary TeethNCT06147609
Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study
A study testing lower lingual holding arch space maintainer and Removable partial denture space maintainer in people with Premature Loss of Primary Teeth, run by Suez Canal University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, pH, viscosity and buffering capacity). Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Loss of Primary Teeth
- What is being tested?
- lower lingual holding arch space maintainer and Removable partial denture space maintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2024to Dec 2024
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy with no systemic disease. Age between 7-10 years old. Both boys and girls will be included.
- Children with the following dental criteria:
- Clinical criteria:
- Children should have a good oral hygiene.
- Children in mixed dentition stage.
- Fully erupted permanent lower first molar.
Show all 11Show fewer
- Children with multiple loss of deciduous molar teeth.
- Seek for space maintainer appliance.
- Radiographic criteria :
- Presence of at least 1mm bone overlaying successor.
- Tooth germ with less than one third of the root formed.
Who cannot join
- Allergy to any used material
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Suez Canal University
Ismailia
Ismail Dahshan, PhD, 00201012715799, dahshan1663@outlook.com
About this study
The aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, pH, viscosity and buffering capacity).
Read the detailed description
This study is a randomized clinical trial, it will be conducted on forty children, aged from (7-10) years, who are in need for space maintainer.
- Children will be randomly and equally divided into two groups according to type of space maintainer used; group (1): twenty children with lower lingual holding arch, group (2): twenty children with removable partial denture.
- Un-stimulated and stimulated saliva will be collected at specific duration of time from children before the delivery of the appliance and after 1, 3 and 6 months of wearing the space maintainer to measure salivary flow rate, pH, viscosity and buffering capacity.
- Conditions
- Premature Loss of Primary Teeth
- Being tested
- lower lingual holding arch space maintainer, Removable partial denture space maintainer
- Keywords
- Teeth loss, Missing teeth
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower lingual holding arch space maintainerDevice
lower lingual holding arch space maintainer is an orthodontic device which connects two molars lower dental arch. it has an archwire, adapted to the lingual side of the lower anterior teeth, that soldered to the bands on first permanent molar
Removable partial denture space maintainerDevice
Removable Partial Denture consists of a pink or gum-colored plastic base to which the new, artificial, replacement teeth are attached to. a metal framework holds the denture in place inside the mouth
| Study group | Role | What they receive |
|---|---|---|
| children with lower lingual holding arch space maintainer | Active comparator | non functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar Receives: Device: lower lingual holding arch space maintainer |
| children with removable partial denture space maintainer | Active comparator | functional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured Receives: Device: Removable partial denture space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of salivary flow of un-stimulated saliva
Un-stimulated whole saliva will be collected from all individuals by direct expectoration into a sterile container over a period of 10 min by spitting method, so that the flow rate could be calculated by dividing the amount of expectorated saliva by 10 min
Measured: before delivery of appliance, after 1 month, 3 months, 6 months
Assessment of salivary flow of stimulated saliva
To stimulate saliva, the subjects will be asked to chew a piece of paraffin wax, and saliva will be collected for 5 min in a measuring cup with 1ml gradation marks; the stimulated salivary flow rate (ml/min) will be calculated by dividing the amount of expectorated saliva by 5 min
Measured: before delivery of appliance, after 1 month, 3 months, 6 months
Assessment of Salivary pH
Salivary pH will be measured using an electronic pH meter
Measured: before delivery of appliance, after 1 month, 3 months, 6 months
Assessment of viscosity of saliva
Salivary viscosity will be determined by allowing saliva to flow through a tube of circular cross section to measure the flow rate . This will be done using the Ostwald viscometer.
Measured: before delivery of appliance, after 1 month, 3 months, 6 months
Assessment of buffering capacity
By estimating the pH change after HCl titration into un-stimulated saliva for a buffering capacity test.
Measured: before delivery of appliance, after 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Premature Loss of Primary TeethStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yousra S Mohamed, PhD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147609
- Sponsor's protocol ID
- space maintainers and saliva
- Status last verified
- Jan 2024
- First submitted
- 17 Nov 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alessandri Bonetti G, Incerti Parenti S, Garulli G, Gatto MR, Checchi L. Effect of fixed orthodontic appliances on salivary properties. Prog Orthod. 2013 Jun 18;14:13. doi: 10.1186/2196-1042-14-13.
PubMed 24326149Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
PubMed 24049221Dallel I, Ben Salem I, Merghni A, Bellalah W, Neffati F, Tobji S, Mastouri M, Ben Amor A. Influence of orthodontic appliance type on salivary parameters during treatment. Angle Orthod. 2020 Jul 1;90(4):532-538. doi: 10.2319/082919-562.1.
PubMed 33378497Essawy K., Gomaa Y. & Khattab N. (2021). 'Clinical Performance of CAD /CAM Fixed Functional Space Maintainer Made of Poly Ether Ether Ketone (PEEK)'. Minia Journal of Medical Research, 32(4): pp.7-12. doi: 10.21608/mjmr.2021.241647
Govindaraj S., Daniel M., & Vasudevan S. & Kumaran J. (2019). 'Changes in Salivary Flow Rate, pH, and Viscosity Among Working Men and Women'. Dentistry and Medical Research, 7(2): pp. 56-59. doi:10.4103/dmr.dmr_20_19.
Kandhan T., Jeevanandan G. & Rajasekar A. (2019). 'Prevalence of Lingual Arch Space Maintainer Among Children Between the Age Groups Of 6-10 Years - A Retrospective Study'. International Journal of Dentistry and Oral Science, 8(5): pp. 21-25. doi:10.19070/2377-8075-SI02-08005.
Kizilci E., Arikan V., Ozalp N. & Ozcelik B. (2021) 'The Effect of Space Maintainers on Salivary pH, Flow Rate, and the Oral Microflora'. Australasian Orthodontic Journal, 37(2): pp.259-264. doi:10.21307/aoj-2021.028
Kukreja P, Hugar SM, Hallikerimath S, Sogi S, Badakar C, Thakkar P. Evaluation of the Effect of Fixed and Removable Appliances on Salivary Parameters (Salivary Flow Rate pH and Buffering Capacity) in Children Aged 5-12 Years: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Nov-Dec;14(6):774-778. doi: 10.5005/jp-journals-10005-2066.
PubMed 35110870Moritsuka M, Kitasako Y, Burrow MF, Ikeda M, Tagami J. The pH change after HCl titration into resting and stimulated saliva for a buffering capacity test. Aust Dent J. 2006 Jun;51(2):170-4. doi: 10.1111/j.1834-7819.2006.tb00422.x.
PubMed 16848266Mosharrafian S, Baghalian A, Hamrah MH, Kargar M. Clinical Evaluation for Space Maintainer after Unilateral Loss of Primary First Molar in the Early Mixed Dentition Stage. Int J Dent. 2021 Dec 27;2021:3967164. doi: 10.1155/2021/3967164. eCollection 2021.
PubMed 34987584Ramakrishnan M, Dhanalakshmi R, Subramanian EMG. Survival rate of different fixed posterior space maintainers used in Paediatric Dentistry - A systematic review. Saudi Dent J. 2019 Apr;31(2):165-172. doi: 10.1016/j.sdentj.2019.02.037. Epub 2019 Feb 14.
PubMed 30983825Sathyaprasad S, Krishnareddy MG, Vinod V, Das N, Ramesh R, Ilyas I. Comparative Evaluation of Fixed Functional Cantilever Space Maintainer and Fixed Nonfunctional Space Maintainer: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):750-760. doi: 10.5005/jp-journals-10005-2478.
PubMed 36866140Sethuraman G., Daniel M., Vasudevan S. & Kumaran J. (2019). 'Changes in Salivary Flow Rate, pH, and Viscosity among Working Men and Women'. Dentistry and Medical Research, 7(2): pp. 56-59. doi: 10.4103/dmr.dmr_20_19
Srivastava V.(2011). 'Modern Pediatric Dentistry '.1 st edition. Jaypee Brothers Medical Publishers (P) Ltd, India: pp. 95-99
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study
- ClinicalTrials.gov ID
- NCT06147609
- Acronym / sponsor ID
- space maintainers and saliva
- Conditions
- Premature Loss of Primary Teeth
- Keywords
- Teeth loss, Missing teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Nov 2023 (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.
The aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, pH, viscosity and buffering capacity).
Detailed description
This study is a randomized clinical trial, it will be conducted on forty children, aged from (7-10) years, who are in need for space maintainer.
- Children will be randomly and equally divided into two groups according to type of space maintainer used; group (1): twenty children with lower lingual holding arch, group (2): twenty children with removable partial denture.
- Un-stimulated and stimulated saliva will be collected at specific duration of time from children before the delivery of the appliance and after 1, 3 and 6 months of wearing the space maintainer to measure salivary flow rate, pH, viscosity and buffering capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with lower lingual holding arch space maintainer | Active comparator | Device: lower lingual holding arch space maintainernon functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar |
| children with removable partial denture space maintainer | Active comparator | Device: Removable partial denture space maintainerfunctional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Apparently healthy with no systemic disease. Age between 7-10 years old. Both boys and girls will be included.
- Children should have a good oral hygiene.
- Children in mixed dentition stage.
- Fully erupted permanent lower first molar.
- Children with multiple loss of deciduous molar teeth.
Key exclusion criteria (1 listed)
- Allergy to any used material
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 |
|---|---|---|
| lower lingual holding arch space maintainerlower lingual holding arch space maintainer is an orthodontic device which connects two molars lower dental arch. it has an archwire, adapted to the lingual side of the lower anterior teeth, that soldered to the bands on first permanent molar | Device | children with lower lingual holding arch space maintainer |
| Removable partial denture space maintainerRemovable Partial Denture consists of a pink or gum-colored plastic base to which the new, artificial, replacement teeth are attached to. a metal framework holds the denture in place inside the mouth | Device | children with removable partial denture space maintainer |
Primary outcome
Assessment of salivary flow of un-stimulated saliva
Time frame: before delivery of appliance, after 1 month, 3 months, 6 months
Un-stimulated whole saliva will be collected from all individuals by direct expectoration into a sterile container over a period of 10 min by spitting method, so that the flow rate could be calculated by dividing the amount of expectorated saliva by 10 min
Assessment of salivary flow of stimulated saliva
Time frame: before delivery of appliance, after 1 month, 3 months, 6 months
To stimulate saliva, the subjects will be asked to chew a piece of paraffin wax, and saliva will be collected for 5 min in a measuring cup with 1ml gradation marks; the stimulated salivary flow rate (ml/min) will be calculated by dividing the amount of expectorated saliva by 5 min
Assessment of Salivary pH
Time frame: before delivery of appliance, after 1 month, 3 months, 6 months
Salivary pH will be measured using an electronic pH meter
Assessment of viscosity of saliva
Time frame: before delivery of appliance, after 1 month, 3 months, 6 months
Salivary viscosity will be determined by allowing saliva to flow through a tube of circular cross section to measure the flow rate . This will be done using the Ostwald viscometer.
Assessment of buffering capacity
Time frame: before delivery of appliance, after 1 month, 3 months, 6 months
By estimating the pH change after HCl titration into un-stimulated saliva for a buffering capacity test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 24326149Alessandri Bonetti G, Incerti Parenti S, Garulli G, Gatto MR, Checchi L. Effect of fixed orthodontic appliances on salivary properties. Prog Orthod. 2013 Jun 18;14:13. doi: 10.1186/2196-1042-14-13.
- Background: PubMed 24049221Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
- Background: PubMed 33378497Dallel I, Ben Salem I, Merghni A, Bellalah W, Neffati F, Tobji S, Mastouri M, Ben Amor A. Influence of orthodontic appliance type on salivary parameters during treatment. Angle Orthod. 2020 Jul 1;90(4):532-538. doi: 10.2319/082919-562.1.
- BackgroundEssawy K., Gomaa Y. & Khattab N. (2021). 'Clinical Performance of CAD /CAM Fixed Functional Space Maintainer Made of Poly Ether Ether Ketone (PEEK)'. Minia Journal of Medical Research, 32(4): pp.7-12. doi: 10.21608/mjmr.2021.241647
- BackgroundGovindaraj S., Daniel M., & Vasudevan S. & Kumaran J. (2019). 'Changes in Salivary Flow Rate, pH, and Viscosity Among Working Men and Women'. Dentistry and Medical Research, 7(2): pp. 56-59. doi:10.4103/dmr.dmr_20_19.
- BackgroundKandhan T., Jeevanandan G. & Rajasekar A. (2019). 'Prevalence of Lingual Arch Space Maintainer Among Children Between the Age Groups Of 6-10 Years - A Retrospective Study'. International Journal of Dentistry and Oral Science, 8(5): pp. 21-25. doi:10.19070/2377-8075-SI02-08005.
- BackgroundKizilci E., Arikan V., Ozalp N. & Ozcelik B. (2021) 'The Effect of Space Maintainers on Salivary pH, Flow Rate, and the Oral Microflora'. Australasian Orthodontic Journal, 37(2): pp.259-264. doi:10.21307/aoj-2021.028
- Background: PubMed 35110870Kukreja P, Hugar SM, Hallikerimath S, Sogi S, Badakar C, Thakkar P. Evaluation of the Effect of Fixed and Removable Appliances on Salivary Parameters (Salivary Flow Rate pH and Buffering Capacity) in Children Aged 5-12 Years: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Nov-Dec;14(6):774-778. doi: 10.5005/jp-journals-10005-2066.
- Background: PubMed 16848266Moritsuka M, Kitasako Y, Burrow MF, Ikeda M, Tagami J. The pH change after HCl titration into resting and stimulated saliva for a buffering capacity test. Aust Dent J. 2006 Jun;51(2):170-4. doi: 10.1111/j.1834-7819.2006.tb00422.x.
- Background: PubMed 34987584Mosharrafian S, Baghalian A, Hamrah MH, Kargar M. Clinical Evaluation for Space Maintainer after Unilateral Loss of Primary First Molar in the Early Mixed Dentition Stage. Int J Dent. 2021 Dec 27;2021:3967164. doi: 10.1155/2021/3967164. eCollection 2021.
- Background: PubMed 30983825Ramakrishnan M, Dhanalakshmi R, Subramanian EMG. Survival rate of different fixed posterior space maintainers used in Paediatric Dentistry - A systematic review. Saudi Dent J. 2019 Apr;31(2):165-172. doi: 10.1016/j.sdentj.2019.02.037. Epub 2019 Feb 14.
- Background: PubMed 36866140Sathyaprasad S, Krishnareddy MG, Vinod V, Das N, Ramesh R, Ilyas I. Comparative Evaluation of Fixed Functional Cantilever Space Maintainer and Fixed Nonfunctional Space Maintainer: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):750-760. doi: 10.5005/jp-journals-10005-2478.
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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.
Yousra S Mohamed, PhD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower lingual holding arch space maintainer and Removable partial denture space maintainer in people with Premature Loss of Primary Teeth, run by Suez Canal University at 1 site in Egypt.
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 11 inclusion and 1 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 8 Jan 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALaa N Abd Ellatif (01025757541, PGS.03220001@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of salivary flow of un-stimulated saliva (time frame: before delivery of appliance, after 1 month, 3 months, 6 months). The study lists 5 primary outcomes in all. 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 NCT06147609, which also lists 14 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 8 Jan 2024.