Peri-Implantitis and Peri-implant Mucositismineral-perioNCT05897736
Salivary Minerals in Patients With Peri-implantitis
An observational study of Peri-Implantitis and Peri-implant Mucositis and Peri-implant Mucositis, run by University of Zagreb.
Trial summary
Patients included in the study will be recruited after arriving at the Faculty of Dentistry of the University of Zagreb. During the clinical examination, the patient's periodontal status (bleeding during probing, and the depth of the pockets around the implant) and a control x-ray will be taken to check bone loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis and Peri-implant Mucositis, Peri-implant Mucositis, Periimplant Bone Loss
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Sep 2026
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: •Patients who come for examination and treatment of the inflammatory process of a dental implant, peri-implantitis at School of dental medicine University in Zagreb. In order to confirm the diagnosis of peri-implantitis, the clinical criteria are as follows: • bleeding and/or suppuration during light probing; • probing depth of ≥ 3 mm; • loss of bone level ≥ 1 mm apical from the most coronary part of the intraosseous part of the implant.
Who may be able to join
- diagnosed peri-implantitis
Who cannot join
- uncooperative patient
- younger then 18 years old
Trial locations and contacts
No sites are listed yet.
Dragana Gabrić contact
About this study
Official title: Analysis of Salivary Minerals Level Variations in Patients With Peri-implantitis
Patients included in the study will be recruited after arriving at the Faculty of Dentistry of the University of Zagreb. During the clinical examination, the patient's periodontal status (bleeding during probing, and the depth of the pockets around the implant) and a control x-ray will be taken to check bone loss. Saliva sampling will occur at 3-time points, when establishing the diagnosis of periimplantitis, before the start of therapy, and at the first control after treatment.
Read the detailed description
Work protocol Through the Department of Oral Surgery and the Department of Periodontology, patients with symptoms of peri-implantitis are admitted for a planned intervention or radiological diagnostic-therapeutic procedure within the same day. The number of patients planned for inclusion in this research on changes in the level of salivary minerals in peri-implantitis is 25.
The treatment of peri-implantitis depends on the clinical symptoms, intra- and post-therapeutic complications are not expected, and a control examination is mandatory.
Patient screening Patient selection is based on social and medical criteria. Social criteria - the patient must understand the planned procedure and the postoperative course, agree to the procedure and giving a saliva sample.
Medical criteria - at the time of departure for the planned procedure, the patient's health must be in optimally stable condition if the patient suffers from chronic diseases.
The main clinical parameters are: 1. presence of plaque, 2. presence of BOP, 3. presence of pus, 4. increased probing depth, 5. loss of alveolar bone.
Preparation for the procedure On the day of the examination, the patient comes to the Institute at the agreed time, after which there is a short preparation and, in a pre-established order after a conversation with the researcher, a saliva sample is taken and a dental clinical examination is performed.
Before giving a saliva sample, patients should not eat, smoke or brush their teeth for at least 2 hours before.
Saliva sampling: Just giving a saliva sample is easy. The patient is placed in a quiet place, the method of spontaneous collection of unstimulated saliva is explained to him. Before the very beginning, he rinses his mouth with plain water, and a 5-minute stopwatch is started during which the patient spits the saliva that is produced in his mouth into a previously weighed polystyrene cup. After 5 minutes, the cup with saliva is placed in the freezer until further biochemical analysis, and the patient is referred for a clinical examination. Biochemical analysis: For the salivary minerals determination, a total of 200 μl of unstimulated saliva sample will be mixed with 40 μl of 5% lanthanum oxide and diluted with deionized water to 2.5 ml for atomic absorption spectrophotometry. Due to the strong affinity of calcium to form complexes with salivary proteins, non-centrifuged whole saliva containing both protein-bound and soluble calcium will be used for the assay. The measurements of salivary calcium will be performed by an atomic absorption spectrophotometer.
Clinical examination: the clinical examination will be performed with the help of a graduated periodontal probe. The clinical parameters that will be recorded are:
- Plaque index
- Bleeding after probing with a plastic probe (BOP)
- Supuration, secretion
- Probing depth greater than 3 mm
- Bone loss visible on X-ray.
- Clinical test of stability and mobility.
- The presence of swelling and redness of the mucous membrane
- foetor ex ore
- pain on percussion The treatment of periimplantitis depends on the state of the disease itself. Non-surgical therapy is indicated for peri-implant mucositis, while in the case of further progression of the disease and the appearance of pre-implantitis, non-surgical therapy is only an introduction to treatment, where surgical therapy is the main stage of treatment. For smaller bone defects, the method of choice for treatment is resective surgery, while for larger bone defects, regenerative surgical therapy is indicated.
A control examination is usually scheduled after six weeks. If the bleeding has stopped or decreased and if the probing depths (the depth of the "pockets" around the implant measured with a periodontal probe) have also decreased, the next control is scheduled as needed.
- Conditions
- Peri-Implantitis and Peri-implant Mucositis, Peri-implant Mucositis, Periimplant Bone Loss, Periimplant Diseases, Peri-implant Health
- Keywords
- salivary minerals, peri-implantitis, peri-implant health, salivary biomarkers
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| peri-implant patient | Patients with diagnosed peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of salivary minerals with disease progression/regression
If it is shown that the minerals of bone metabolism change according to the direction of recovery, it is possible to use salivary minerals (calcium, magnesium and phosphates) as an aid in the prognosis of the course of recovery and reduce the time needed to make a decision on the type and intensity of therapy, as well as the loss itself and implant replacement
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study startOct 2023 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implantitis and Peri-implant MucositisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Sutej, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897736
- Sponsor's protocol ID
- 1-Mineral-Peri-Imp
- Acronym
- mineral-perio
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Salivary Minerals Level Variations in Patients With Peri-implantitis
- ClinicalTrials.gov ID
- NCT05897736
- Acronym / sponsor ID
- mineral-perio / 1-Mineral-Peri-Imp
- Conditions
- Peri-Implantitis and Peri-implant Mucositis, Peri-implant Mucositis, Periimplant Bone Loss, Periimplant Diseases, Peri-implant Health
- Keywords
- salivary minerals, peri-implantitis, peri-implant health, salivary biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 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.
Patients included in the study will be recruited after arriving at the Faculty of Dentistry of the University of Zagreb. During the clinical examination, the patient's periodontal status (bleeding during probing, and the depth of the pockets around the implant) and a control x-ray will be taken to check bone loss. Saliva sampling will occur at 3-time points, when establishing the diagnosis of periimplantitis, before the start of therapy, and at the first control after treatment.
Detailed description
Work protocol Through the Department of Oral Surgery and the Department of Periodontology, patients with symptoms of peri-implantitis are admitted for a planned intervention or radiological diagnostic-therapeutic procedure within the same day. The number of patients planned for inclusion in this research on changes in the level of salivary minerals in peri-implantitis is 25.
The treatment of peri-implantitis depends on the clinical symptoms, intra- and post-therapeutic complications are not expected, and a control examination is mandatory.
Patient screening Patient selection is based on social and medical criteria. Social criteria - the patient must understand the planned procedure and the postoperative course, agree to the procedure and giving a saliva sample.
Medical criteria - at the time of departure for the planned procedure, the patient's health must be in optimally stable condition if the patient suffers from chronic diseases.
The main clinical parameters are: 1. presence of plaque, 2. presence of BOP, 3. presence of pus, 4. increased probing depth, 5. loss of alveolar bone.
Preparation for the procedure On the day of the examination, the patient comes to the Institute at the agreed time, after which there is a short preparation and, in a pre-established order after a conversation with the researcher, a saliva sample is taken and a dental clinical examination is performed.
Before giving a saliva sample, patients should not eat, smoke or brush their teeth for at least 2 hours before.
Saliva sampling: Just giving a saliva sample is easy. The patient is placed in a quiet place, the method of spontaneous collection of unstimulated saliva is explained to him. Before the very beginning, he rinses his mouth with plain water, and a 5-minute stopwatch is started during which the patient spits the saliva that is produced in his mouth into a previously weighed polystyrene cup. After 5 minutes, the cup with saliva is placed in the freezer until further biochemical analysis, and the patient is referred for a clinical examination. Biochemical analysis: For the salivary minerals determination, a total of 200 μl of unstimulated saliva sample will be mixed with 40 μl of 5% lanthanum oxide and diluted with deionized water to 2.5 ml for atomic absorption spectrophotometry. Due to the strong affinity of calcium to form complexes with salivary proteins, non-centrifuged whole saliva containing both protein-bound and soluble calcium will be used for the assay. The measurements of salivary calcium will be performed by an atomic absorption spectrophotometer.
Clinical examination: the clinical examination will be performed with the help of a graduated periodontal probe. The clinical parameters that will be recorded are:
- Plaque index
- Bleeding after probing with a plastic probe (BOP)
- Supuration, secretion
- Probing depth greater than 3 mm
- Bone loss visible on X-ray.
- Clinical test of stability and mobility.
- The presence of swelling and redness of the mucous membrane
- foetor ex ore
- pain on percussion The treatment of periimplantitis depends on the state of the disease itself. Non-surgical therapy is indicated for peri-implant mucositis, while in the case of further progression of the disease and the appearance of pre-implantitis, non-surgical therapy is only an introduction to treatment, where surgical therapy is the main stage of treatment. For smaller bone defects, the method of choice for treatment is resective surgery, while for larger bone defects, regenerative surgical therapy is indicated.
A control examination is usually scheduled after six weeks. If the bleeding has stopped or decreased and if the probing depths (the depth of the "pockets" around the implant measured with a periodontal probe) have also decreased, the next control is scheduled as needed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peri-implant patient | – | –Patients with diagnosed peri-implantitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- •Patients who come for examination and treatment of the inflammatory process of a dental implant, peri-implantitis at School of dental medicine University in Zagreb. In order to confirm the diagnosis of peri-implantitis, the clinical criteria are as follows: • bleeding and/or suppuration during light probing; • probing depth of ≥ 3 mm; • loss of bone level ≥ 1 mm apical from the most coronary part of the intraosseous part of the implant.
Key inclusion criteria (1 listed)
- diagnosed peri-implantitis
Key exclusion criteria (2 listed)
- uncooperative patient
- younger then 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in levels of salivary minerals with disease progression/regression
Time frame: one year
If it is shown that the minerals of bone metabolism change according to the direction of recovery, it is possible to use salivary minerals (calcium, magnesium and phosphates) as an aid in the prognosis of the course of recovery and reduce the time needed to make a decision on the type and intensity of therapy, as well as the loss itself and implant replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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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.
Dragana Gabrić contact
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Peri-implant Mucositis and Peri-implant Mucositis, run by University of Zagreb.
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 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ivana Sutej (+38598739248, isutej@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of salivary minerals with disease progression/regression (time frame: one year). 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 9 Jun 2023.