Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05897736 |
| Other study ID # |
1-Mineral-Peri-Imp |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
September 2026 |
Study information
| Verified date |
June 2023 |
| Source |
University of Zagreb |
| Contact |
Ivana Sutej |
| Phone |
+38598739248 |
| Email |
isutej[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
