Peri-implant MucositisNCT04415801
Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants
A study testing Repeated removal and re-placement of healing and prosthetic abutments in people with Peri-implant Mucositis, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Repeated removal and re-placement of healing and prosthetic abutments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 31 May 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, in good general health, and with sufficient amount of bone available to place a standard implant
Who cannot join
- natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,
Trial locations and contacts
1 site in 1 country.
Renzo Guarnieri contact
Italy1 site, 1 recruiting
- Recruiting
Universita la Sapienza
Roma, 00100
Renzi Guarnieri, MD DDS, +39 342 5224458, renzoguarnieri@gmail.com
About this study
Official title: Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants
Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after functional loading, on proinflammatory cytokine levels around dental implants.
Read the detailed description
Twenty-four patients each received 2 one-stage implants in a split mouth design on the same jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS group) were used. Four months following implant placement [Baseline (BSL)], the healing abutments were disconnnected and reconnected three times to carry out the impression procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments were installated with screw retained crowns. Samples for immunological analyses were taken from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1). Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.
- Conditions
- Peri-implant Mucositis
- Being tested
- Repeated removal and re-placement of healing and prosthetic abutments
- Keywords
- Peri-implant Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated removal and re-placement of healing and prosthetic abutmentsDiagnostic test
Repeated removal and re-placement of healing and prosthetic abutments
| Study group | Role | What they receive |
|---|---|---|
| Implant abutments | Experimental | implant abutments Receives: Diagnostic Test: Repeated removal and re-placement of healing and prosthetic abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline to 8 weeks of gingival fluid production
The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 May 2020
- Primary completion31 May 2020
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renzo Guarnieri, University of Roma La Sapienza
- Investigators
- Renzo Guarnieri, Principal investigator, University La Sapienza Roma Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415801
- Sponsor's protocol ID
- 3/20
- Status last verified
- May 2020
- First submitted
- 24 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guarnieri R, Miccoli G, Reda R, Mazzoni A, Di Nardo D, Testarelli L. Laser microgrooved vs. machined healing abutment disconnection/reconnection: a comparative clinical, radiographical and biochemical study with split-mouth design. Int J Implant Dent. 2021 Mar 17;7(1):19. doi: 10.1186/s40729-021-00301-6.
PubMed 33728493
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants
- ClinicalTrials.gov ID
- NCT04415801
- Acronym / sponsor ID
- 3/20
- Conditions
- Peri-implant Mucositis
- Keywords
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 4 Jun 2020 (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.
Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after functional loading, on proinflammatory cytokine levels around dental implants.
Detailed description
Twenty-four patients each received 2 one-stage implants in a split mouth design on the same jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS group) were used. Four months following implant placement [Baseline (BSL)], the healing abutments were disconnnected and reconnected three times to carry out the impression procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments were installated with screw retained crowns. Samples for immunological analyses were taken from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1). Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant abutments | Experimental | Diagnostic Test: Repeated removal and re-placement of healing and prosthetic abutmentsimplant abutments |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, in good general health, and with sufficient amount of bone available to place a standard implant
Key exclusion criteria (1 listed)
- natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,
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 |
|---|---|---|
| Repeated removal and re-placement of healing and prosthetic abutmentsRepeated removal and re-placement of healing and prosthetic abutments | Diagnostic test | Implant abutments |
Primary outcome
change from baseline to 8 weeks of gingival fluid production
Time frame: 8 weeks
The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 33728493Guarnieri R, Miccoli G, Reda R, Mazzoni A, Di Nardo D, Testarelli L. Laser microgrooved vs. machined healing abutment disconnection/reconnection: a comparative clinical, radiographical and biochemical study with split-mouth design. Int J Implant Dent. 2021 Mar 17;7(1):19. doi: 10.1186/s40729-021-00301-6.
- Individual participant dataSharing planned: No
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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.
Renzo Guarnieri contact
Renzo Guarnieri principal investigator
University La Sapienza Roma Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated removal and re-placement of healing and prosthetic abutments in people with Peri-implant Mucositis, run by University of Roma La Sapienza at 1 site in Italy.
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 1 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 5 Jun 2020. 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 Italy. 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 Renzo Guarnieri, MD DDS (+39 3425224458, renzoguarnieri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline to 8 weeks of gingival fluid production (time frame: 8 weeks). 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 NCT04415801, which also lists 1 linked publication.
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 5 Jun 2020.