Bleeding of Subgingival SpaceNCT05923554
Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous
A study testing Changes in Probing Depth to non-surgical periodontal therapy in people with Bleeding of Subgingival Space, run by University of Catania at 1 site in Italy.
Trial summary
The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleeding of Subgingival Space
- What is being tested?
- Changes in Probing Depth to non-surgical periodontal therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2023to 31 Oct 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- peri-implant mucositis
- bleeding on probing and/or a gingival index <1 at least at one site at baseline
- absence of peri-implant bone loss during the last 2 years before baseline
Who cannot join
- Periodontal disease
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
Rosalia Leonardi contact
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico G. Rodolico
Catania, 95124
Gaetano Isola, DDS, +3909537800
About this study
Official title: Impact of Non-surgical Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous on a Single Tooth Restoration
The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration.
Read the detailed description
The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration by comparing two groups of patients with peri-implant mucositis.
- Conditions
- Bleeding of Subgingival Space
- Being tested
- Changes in Probing Depth to non-surgical periodontal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in Probing Depth to non-surgical periodontal therapyOther
Changes in Probing Depth following non surgical periodontal treatment performed with hand and ultrasonic tips
| Study group | Role | What they receive |
|---|---|---|
| Un-congruous single tooth peri implantitis | Active comparator | Patients were treated through non-surgical periodontal treatment for the peri-implant mucositis resolution Receives: Other: Changes in Probing Depth to non-surgical periodontal therapy |
| Congruous single tooth peri implantitis | Placebo comparator | Patients were treated through non-surgical periodontal treatment for the peri implant mucositis resolution Receives: Other: Changes in Probing Depth to non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing change % reduction
Reduction in bleeding on probing % change following non surgical periodontal therapy
Measured: 6-months
Secondary outcomes (1)
Reduction of probing depth in mm
Reduction of probing depth following non surgical periodontal therapy
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start25 May 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding of Subgingival SpaceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- After non-randomization, patients were assigned to a group with un-congruous single-tooth prostheses and a group with congruous single-tooth prostheses. Patients received a one-stage full-mouth scaling without chlorhexidine. Clinical and microbiological examination was performed at baseline, after 1, 2, and 3 months.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, Università degli Studi di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923554
- Sponsor's protocol ID
- 22-150-PO
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-surgical Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous on a Single Tooth Restoration
- ClinicalTrials.gov ID
- NCT05923554
- Acronym / sponsor ID
- 22-150-PO
- Conditions
- Bleeding of Subgingival Space
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 28 Jun 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 the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration.
Detailed description
The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration by comparing two groups of patients with peri-implant mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After non-randomization, patients were assigned to a group with un-congruous single-tooth prostheses and a group with congruous single-tooth prostheses. Patients received a one-stage full-mouth scaling without chlorhexidine. Clinical and microbiological examination was performed at baseline, after 1, 2, and 3 months.
| Arm | Type | Receives |
|---|---|---|
| Un-congruous single tooth peri implantitis | Active comparator | Other: Changes in Probing Depth to non-surgical periodontal therapyPatients were treated through non-surgical periodontal treatment for the peri-implant mucositis resolution |
| Congruous single tooth peri implantitis | Placebo comparator | Other: Changes in Probing Depth to non-surgical periodontal therapyPatients were treated through non-surgical periodontal treatment for the peri implant mucositis resolution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- peri-implant mucositis
- bleeding on probing and/or a gingival index <1 at least at one site at baseline
- absence of peri-implant bone loss during the last 2 years before baseline
Key exclusion criteria (2 listed)
- Periodontal disease
- Systemic diseases
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 |
|---|---|---|
| Changes in Probing Depth to non-surgical periodontal therapyChanges in Probing Depth following non surgical periodontal treatment performed with hand and ultrasonic tips | Other | Congruous single tooth peri implantitis, Un-congruous single tooth peri implantitis |
Primary outcome
Bleeding on probing change % reduction
Time frame: 6-months
Reduction in bleeding on probing % change following non surgical periodontal therapy
1 secondary outcome
Reduction of probing depth in mm
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Yes. Study results
Related trials for Bleeding of Subgingival Space
Active, not recruitingObservational study
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
Peri-Implantitis, Bleeding of Subgingival Space
Recruiting
Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
Dental Plaque, Bleeding of Subgingival Space
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.
Rosalia Leonardi contact
Gaetano Isola principal investigator
Università degli Studi di Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changes in Probing Depth to non-surgical periodontal therapy in people with Bleeding of Subgingival Space, run by University of Catania 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 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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. Some participants in this study may receive a placebo. 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 Gaetano Isola (0953785652, gaetano.isola@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing change % reduction (time frame: 6-months). 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 28 Jun 2023.