Gingivitis and Periodontal DiseasesNCT04015427
Cement Excess at Single Implant Crowns Malmö/Lund
A study testing implant crown in people with Gingivitis and Periodontal Diseases and Tooth Loss, run by University of Zurich at 1 site in Sweden.
Trial summary
Abstract Aim: The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases, Tooth Loss
- What is being tested?
- implant crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 27 Jun 2018to 30 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - patient older than 18 years
- systemically healthy subject
- periodontally healthy individuals
- absence of peri-implantitis
- no bone loss
- good oral hygiene (PCR ≤ 20%)
Show all 9Show fewer
- healthy periodontal tissues (BoP≤ 20%)
- patients with a single tooth gap in the posterior area of either jaw (premolars and molars)
- at least 8mm in mandible; at least 6mm in maxilla (summers technique)
Who cannot join
- - ongoing periodontal disease
- bruxism
- unwilling to comply with study procedures
- heavy smokers (≥10 cig/d)
- ongoing periodontitis/implantitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Microbiological and Histological Effects of Cemented Implant Restorations. A Cross-over Controlled Clinical Study
Abstract
Aim:
Read more
The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues.
Material and Methods:
24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups.
Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.
In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A.
After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.
- Conditions
- Gingivitis and Periodontal Diseases, Tooth Loss
- Being tested
- implant crown
- Keywords
- cement, dental, implant, implant prosthodontics
- Medical subject headings
- Gingivitis, Periodontal Diseases, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant crownDevice
After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.
| Study group | Role | What they receive |
|---|---|---|
| screw-retained | Active comparator | Patients in group A will receive a screw-retained implant crown. Following this first period of 16 weeks, the screw-retained implant crown will be replaced by a new intraorally cemented implant crown. Cement removal will be preformed according to best clinical procedure. These implant crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the implant crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained implant crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period. Receives: Device: implant crown |
| cement-retained | Active comparator | In group B the implant crowns will be incorporated in a reverse pattern. During the first 16 weeks a cemented implant crown will be inserted and any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single implant crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A. Receives: Device: implant crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of microbiological parameters
Change relative percentage of gram-negative microorganisms
Measured: Change BL to 16 weeks post-restoration
Secondary outcomes (9)
Histomorphometric analysis
A soft tissue biopsy will be harvested at the time of insertion of the final screw-retained implant crown in all patients. The biopsies will be used for histomorphometric measurements.
Measured: 32 weeks after BL
Immunohistologic analysis - putative periodontal pathogens
The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips. A battery of 10 putative periodontal pathogens will be analyzed using real-time PCR.
Measured: 32 weeks after BL
Immunohistologic analysis - MMP8
The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips.
Measured: 32 weeks after BL
Immunohistologic analysis - IL1ß
The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips.
Measured: 32 weeks after BL
Analysis of inflammation markers on RNA-basis - (IL-4, IL-3, IL-1alfa, IL-1beta)
Tissue samples will further be processed with a (ribonucleic acid) RNA solution to allow for RNA extraction. This will then be analyzed via polymerase chain reaction (PCR) to determine expression patterns of markers such as Interleukin (IL-4, IL-3, IL-1alfa, IL-1beta) and tumor necrose factor (TNF-alfa).
Measured: 32 weeks after BL
Analysis of inflammation markers on RNA-basis - TNF-alfa
Tissue samples will further be processed with a (ribonucleic acid) RNA solution to allow for RNA extraction. This will then be analyzed via polymerase chain reaction (PCR) to determine expression patterns of markers such as Interleukin (IL-4, IL-3, IL-1alfa, IL-1beta) and tumor necrose factor (TNF-alfa).
Measured: 32 weeks after BL
Clinical parameters - Probing Depth
In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous)
Measured: Every 8 weeks until 48 weeks and again at the 1-year follow-up
Clinical parameters - Bleeding-on-Probing
In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous)
Measured: Every 8 weeks until 48 weeks and again at the 1-year follow-up
Clinical parameters - Plaque Index
In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous)
Measured: Every 8 weeks until 48 weeks and again at the 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start27 Jun 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis and Periodontal DiseasesStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Folktandvården Skåne AB, Göteborg University, Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015427
- Sponsor's protocol ID
- 2018-414
- Status last verified
- Jun 2022
- First submitted
- 11 Oct 2018
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the scans of the sealed randomization envelopes will be sent to the center in Lund, Sweden whenever a patient is included and ready to take the impression. A folder structure on switch drive is set up with the Subject numbers (1-24) in order to upload the CRFs, photographs and X rays.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Microbiological and Histological Effects of Cemented Implant Restorations. A Cross-over Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04015427
- Acronym / sponsor ID
- 2018-414
- Conditions
- Gingivitis and Periodontal Diseases, Tooth Loss
- Keywords
- cement, dental, implant, implant prosthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Folktandvården Skåne AB, Göteborg University, Dentsply Sirona Implants and Consumables
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 11 Jul 2019 (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.
Abstract
Aim:
The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues.
Material and Methods:
24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups.
Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.
In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A.
After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screw-retained | Active comparator | Device: implant crownPatients in group A will receive a screw-retained implant crown. Following this first period of 16 weeks, the screw-retained implant crown will be replaced by a new intraorally cemented implant crown. Cement removal will be preformed according to best clinical procedure. These implant crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the implant crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained implant crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period. |
| cement-retained | Active comparator | Device: implant crownIn group B the implant crowns will be incorporated in a reverse pattern. During the first 16 weeks a cemented implant crown will be inserted and any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single implant crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - patient older than 18 years
- systemically healthy subject
- periodontally healthy individuals
- absence of peri-implantitis
- no bone loss
Key exclusion criteria (5 listed)
- - ongoing periodontal disease
- bruxism
- unwilling to comply with study procedures
- heavy smokers (≥10 cig/d)
- ongoing periodontitis/implantitis
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 |
|---|---|---|
| implant crownAfter the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period. | Device | cement-retained, screw-retained |
Primary outcome
Analysis of microbiological parameters
Time frame: Change BL to 16 weeks post-restoration
Change relative percentage of gram-negative microorganisms
9 secondary outcomes
Histomorphometric analysis
Time frame: 32 weeks after BL
Immunohistologic analysis - putative periodontal pathogens
Time frame: 32 weeks after BL
Immunohistologic analysis - MMP8
Time frame: 32 weeks after BL
Immunohistologic analysis - IL1ß
Time frame: 32 weeks after BL
Analysis of inflammation markers on RNA-basis - (IL-4, IL-3, IL-1alfa, IL-1beta)
Time frame: 32 weeks after BL
Analysis of inflammation markers on RNA-basis - TNF-alfa
Time frame: 32 weeks after BL
Clinical parameters - Probing Depth
Time frame: Every 8 weeks until 48 weeks and again at the 1-year follow-up
Clinical parameters - Bleeding-on-Probing
Time frame: Every 8 weeks until 48 weeks and again at the 1-year follow-up
Clinical parameters - Plaque Index
Time frame: Every 8 weeks until 48 weeks and again at the 1-year follow-up
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 14 Jun 2022.
- Individual participant dataSharing planned: Yes. the scans of the sealed randomization envelopes will be sent to the center in Lund, Sweden whenever a patient is included and ready to take the impression. A folder structure on switch drive is set up with the Subject numbers (1-24) in order to upload the CRFs, photographs and X rays.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant crown in people with Gingivitis and Periodontal Diseases and Tooth Loss, run by University of Zurich at 1 site in Sweden.
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 9 inclusion and 5 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 14 Jun 2022. 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 Sweden. 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?
Analysis of microbiological parameters (time frame: Change BL to 16 weeks post-restoration). 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 14 Jun 2022.