Jaw, Edentulous, PartiallyNCT06580483
Assessment of Two Filling Materials for Teeth-tissue Supported Overdenture
A study testing amalgam restoration and nano-composite in people with Jaw, Edentulous, Partially, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Methods: 28 patients with bilateral remaining first premolar in the maxillary or mandibular arch were enrolled in the study. Dome shaped preparations of the abutments were performed. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- amalgam restoration and nano-composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2021to 15 Jun 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presented with partially edentulous maxillary and mandibular arches particularly with bilaterally remaining any of these teeth ; #33 #34 #35 #43 #44 #45 #13 # 14#15 #23 # 24 #25
- Good periodontal support and grade I mobility.
- They were medically free.
Who cannot join
- Medically compromised
- Grade II and grade III mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Two Filling Materials As Restorative Options for Tooth-tissue Supported Overdenture: a Split-mouth Randomized Trial
Methods: 28 patients with bilateral remaining first premolar in the maxillary or mandibular arch were enrolled in the study. Dome shaped preparations of the abutments were performed. The amalgam and composite restorations were randomly assigned to either the right or left remaining premolar; then conventional steps of overdenture fabrication and insertion were accomplished. Patients were followed up for 3 years.
Read the detailed description
For all cases, root planning and supra- and subgingival scaling were carried out utilizing an ultrasonic scaler. For all cases, all teeth were cleaned, shaped, and obturated during the patients' first visit. Local anaesthesia was achieved by local infiltration. After anaesthesia, an endodontic access cavity was established. Canals were prepared using the crowndown technique. The ideal working length was determined using an electronic apex locator and periapical radiographs. The canals were cleaned and shaped. The final instrumentation size was determined as three sizes larger than the first file binding at the working length. Master apical files ranged from #25 to #50, depending on both root anatomy and initial diameter of the root canal.Irrigation was always performed with 5.25% NaOCl solution. Obturation using gutta-percha. The master gutta-percha cone was coated with AH Plus, obturation was carried out utilizing the lateral compaction technique. Afterwards, selective etching of enamel for 30 seconds then rinsing and dryness were done followed by application of universal bonding agent with agitation action which was then light cured for 20 seconds. It was then followed by core buildup with light cured Nano-filled composite body.. As for the amalgam, high-copper non-gamma 2 spherical and lathe cut amalgam was used. For all patients, fabrication of new dentures was employed.
Data were statistically described in terms of mean, standard deviation (SD), 95% CI, median and range. Data were tested for the normal assumption using Kolmogorov Smirnov test. Comparison between the study groups was done using Student t test for independent samples. Two-sided p values less than 0.05 was considered statistically significant. IBM SPSS. Survival analysis was done using Kaplan Maier statistics
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- amalgam restoration, nano-composite
- Keywords
- overdenture, nanocomposite, Amalgam, Survival, Wear
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amalgam restorationOther
An abutment tooth is restored on a side by amalgam plug
nano-compositeOther
An abutment tooth is restored on a side by nano-composite
| Study group | Role | What they receive |
|---|---|---|
| A tooth (on one side) supporting complete overdenture | Experimental | The tooth is prepared to receive a restoration Receives: Other: amalgam restoration |
| A tooth (on the other side) supporting complete overdenture | Active comparator | The tooth is prepared to receive another restoration Receives: Other: nano-composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear depth
For each patient, a scan of the abutments was performed using intra-oral scanner in the day of overdenture insertion and another scan was performed after 36m follow up periods and then both scans are compared
Measured: 36 months
Survival of the restoration
Restoration survival was assessed according to the criteria approved by the FDI World Dental Federation (FDI) Scientific Committee in 2007 and the General Assembly in 2008 as criteria specifically developed for use in clinical trials.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start20 Mar 2021
- Primary completion20 Mar 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wafaa I Ibrahim, Principal investigator, Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580483
- Sponsor's protocol ID
- FODMRC-202100102
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Two Filling Materials As Restorative Options for Tooth-tissue Supported Overdenture: a Split-mouth Randomized Trial
- ClinicalTrials.gov ID
- NCT06580483
- Acronym / sponsor ID
- FODMRC-202100102
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- overdenture, nanocomposite, Amalgam, Survival, Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Aug 2024 (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.
Methods: 28 patients with bilateral remaining first premolar in the maxillary or mandibular arch were enrolled in the study. Dome shaped preparations of the abutments were performed. The amalgam and composite restorations were randomly assigned to either the right or left remaining premolar; then conventional steps of overdenture fabrication and insertion were accomplished. Patients were followed up for 3 years.
Detailed description
For all cases, root planning and supra- and subgingival scaling were carried out utilizing an ultrasonic scaler. For all cases, all teeth were cleaned, shaped, and obturated during the patients' first visit. Local anaesthesia was achieved by local infiltration. After anaesthesia, an endodontic access cavity was established. Canals were prepared using the crowndown technique. The ideal working length was determined using an electronic apex locator and periapical radiographs. The canals were cleaned and shaped. The final instrumentation size was determined as three sizes larger than the first file binding at the working length. Master apical files ranged from #25 to #50, depending on both root anatomy and initial diameter of the root canal.Irrigation was always performed with 5.25% NaOCl solution. Obturation using gutta-percha. The master gutta-percha cone was coated with AH Plus, obturation was carried out utilizing the lateral compaction technique. Afterwards, selective etching of enamel for 30 seconds then rinsing and dryness were done followed by application of universal bonding agent with agitation action which was then light cured for 20 seconds. It was then followed by core buildup with light cured Nano-filled composite body.. As for the amalgam, high-copper non-gamma 2 spherical and lathe cut amalgam was used. For all patients, fabrication of new dentures was employed.
Data were statistically described in terms of mean, standard deviation (SD), 95% CI, median and range. Data were tested for the normal assumption using Kolmogorov Smirnov test. Comparison between the study groups was done using Student t test for independent samples. Two-sided p values less than 0.05 was considered statistically significant. IBM SPSS. Survival analysis was done using Kaplan Maier statistics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A tooth (on one side) supporting complete overdenture | Experimental | Other: amalgam restorationThe tooth is prepared to receive a restoration |
| A tooth (on the other side) supporting complete overdenture | Active comparator | Other: nano-compositeThe tooth is prepared to receive another restoration |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presented with partially edentulous maxillary and mandibular arches particularly with bilaterally remaining any of these teeth ; #33 #34 #35 #43 #44 #45 #13 # 14#15 #23 # 24 #25
- Good periodontal support and grade I mobility.
- They were medically free.
Key exclusion criteria (2 listed)
- Medically compromised
- Grade II and grade III mobility
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 |
|---|---|---|
| amalgam restorationAn abutment tooth is restored on a side by amalgam plug | Other | A tooth (on one side) supporting complete overdenture |
| nano-compositeAn abutment tooth is restored on a side by nano-composite | Other | A tooth (on the other side) supporting complete overdenture |
Primary outcome
Wear depth
Time frame: 36 months
For each patient, a scan of the abutments was performed using intra-oral scanner in the day of overdenture insertion and another scan was performed after 36m follow up periods and then both scans are compared
Survival of the restoration
Time frame: 36 months
Restoration survival was assessed according to the criteria approved by the FDI World Dental Federation (FDI) Scientific Committee in 2007 and the General Assembly in 2008 as criteria specifically developed for use in clinical trials.
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 30 Aug 2024.
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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.
Wafaa I Ibrahim principal investigator
Assoc. Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amalgam restoration and nano-composite in people with Jaw, Edentulous, Partially, run by Delta University for Science and Technology 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 3 inclusion and 2 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 30 Aug 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?
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?
Wear depth (time frame: 36 months). The study lists 2 primary outcomes in all. 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 30 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.