Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05924711 |
| Other study ID # |
PER-ECL-2023-02 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 6, 2023 |
| Est. completion date |
July 15, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Universitat Internacional de Catalunya |
| Contact |
Marta Monzo |
| Phone |
932 54 18 00 |
| Email |
secretariaodonto[@]uic.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Scientific evidence regarding the influence of peri-implantitis on Schneider's membrane
thickening is scarce and limited. Similarly, to date, there is no literature documenting the
resolution of implant-associated maxillary sinusitis with peri-implantitis after treatment of
peri-implantitis or removal of the implant. Therefore, the aim of this case-control study is
to investigate the association between peri-implantitis and maxillary sinusitis. On the other
hand, the changes that occur at the level of the maxillary sinus membrane after treatment of
peri-implantitis or after implant explantation will be evaluated.
Description:
Background Scientific evidence regarding the influence of peri-implantitis on Schneider's
membrane thickening is scarce and limited. Similarly, to date, there is no literature
documenting the resolution of implant-associated maxillary sinusitis with peri-implantitis
after treatment of peri-implantitis or removal of the implant.
Objectives Therefore, the aim of this case-control study is to investigate the association
between peri-implantitis and maxillary sinusitis. On the other hand, the changes that occur
at the level of the maxillary sinus membrane after treatment of peri-implantitis or after
implant explantation will be evaluated.
Hypothesis H01: The presence of implants placed in the posterior maxillary region affected by
peri-implantits is associated with sinus membrane thickening or maxillary sinusitis.
H11: The presence of implants placed in the posterior maxillary region affected by
peri-implantits is not associated with sinus membrane thickening or maxillary sinusitis.
H02: Treatment of peri-implantitis in implants placed in the posterior maxillary region can
resolve maxillary sinusitis or reduce sinus membrane thickening.
H12: Treatment of peri-implantitis on implants placed in the posterior maxillary region
cannot resolve maxillary sinusitis or reduce sinus membrane thickening.
Material and methods Study design The study will present a case-control design. Patients will
be retrospectively recruited from a private clinic exclusively dedicated to periodontics and
implantology (Clínica CICOM, Badajoz, Spain).
Study setting The study will be conducted in a private practice associated with the
Universitat Internacional de Catalunya (UIC). The study protocol and informed consent will be
reviewed by the Ethics Committee of the Universitat Internacional de Catalunya (UIC,
Barcelona, Spain) and the Declaration of Helsinki, 1975, revised in 2013, will be followed.
Study population All patients included in the study will sign the corresponding informed
consent forms for each of the treatments received, as well as for the use of their
demographic and radiographic data for scientific purposes.
The subjects recruited will be edentulous (partial/total) patients who previously had
implants placed in the posterior region of the maxilla for oral rehabilitation. The case
group will consist of 20 patients who will have implants diagnosed with peri-implantitis
while in the control group the 20 subjects included will have implants with peri-implant
health.
Demographic data
A set of demographic data shall be obtained and recorded:
1. Sex (M/F)
2. Age (years)
3. History of periodontal disease (according to the latest classification of periodontal
disease from the report of the "Consensus report of workgroup 4 of the 2017 World
Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions):
severity (I, II, III and IV), grade (A, B and C) and extent (localized, generalized or
inicisive-molar pattern).
4. Type of edentulism: partial or total.
5. Number of implants per patient
6. Smoking (heavy smoker >10 cig/day, light smoker <10 cig/day, ex-smoker 0 cig/day, or
non-smoker 0 cig/day).
7. Position of the implants: premolar region or molar region of the maxilla.
8. Time in function (years)
9. Implant diagnosis (according to the latest classification of periodontal disease from
the "Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of
Periodontal and Peri-Implant Diseases and Conditions): peri-implant health, mucositis or
peri-implantitis.
10. Previous history of maxillary sinusitis
11. Implant-related variables:
1. Implant placed with horizontal bone augmentation (Y/N) or with sinus lift (Y/N and
lateral/transcrestal window).
2. Implant system (diameter, length and type of connection)
3. Implant macro-design (transmucosal or bone level)
Radiographic analysis Images of the included patients will be obtained with the
CBCT-ICAT Model 17-19 (Imaging Sciences International LLC, Hatfield, PA, USA). The
parameters were set as 16x13 mm in width and depth, 120 kVp, 20.27 mAs, scan time
14.7 seconds, resolution at 0.25 voxels and field of view varying according to the
region scanned. Radiographic evaluation will include analysis of implants, adjacent
teeth and maxillary sinuses/sinus membranes.
Radiographic analysis of the implants
A pre-calibrated examiner (RP) will analyze each of the implants included in the
study using the coDiagnostiX software (Implant planning Software, Dental Wings
GmbH, Chemnitz, Germany). The following parameters will be evaluated:
- Peri-implant radiographic bone loss: assessed at 4 sites per implant (mesial,
distal, vestibular and palatal). The distance from the implant platform to the
first bone-to-implant contact (Bone-to-implant contact) in mm shall be measured.
These radiographic measurements shall be repeated again in the case group subjects
after the peri-implantitis has been treated. The time between treatment and the
re-evaluation tac shall be at least 6 months.
Radiographic evaluation of adjacent teeth A pre-calibrated examiner (RP) will
analyze each adjacent tooth for the presence of periapical lesions or carious
lesions using the coDiagnostiX software (Implant planning Software, Dental Wings
GmbH, Chemnitz, Germany). This is recorded as presence or absence.
Radiographic evaluation of the maxillary sinus
A pre-calibrated examiner (BA) will analyze each maxillary sinus using Dolphin 3D
Images software. The following parameters will be evaluated:
- Distance from the apex of the implant to the maxillary sinus: measured from
the apical portion of the maxillary cortex to the apex of the implant
following the longitudinal axis of the implant, measured in mm.
- Sinus membrane thickening (sagittal direction): measured from the cortical
bone of the raised sinus floor to the upper margin of the sinus mucosa at the
point of greatest thickening, measured in mm.
- Thickening of the sinus membrane (coronal): measured from the cortical bone of
the floor of the raised sinus to the upper margin of the sinus mucosa at the
point of greatest thickening, measured in mm.
- Volume of the maxillary sinus occupied by the sinus membrane: the total volume
of the sinus membrane (cm3 and %) shall be calculated compared to the total
volume of the maxillary sinus.
These radiographic measurements will be repeated again in the case group subjects
after treatment of peri-implantitis or after explantation of implants in more
advanced cases. The time between treatment and the re-evaluation tac will be at
least 6 months.
In addition, the following information shall be obtained for each maxillary sinus
and sinus membrane:
- Mucosal inflammation: 0 (clear sinus), 1 (mild membrane thickening) and 2
(moderate membrane thickening).
- Sinus ostium patency: 0 (patent ostium) or 1 (obstructed ostium).
- Implant-to-sinus ratio: 0 (distance between implant apex and sinus with
presence of cancellous bone and cortical bone between implant and sinus), 1
(implant contacts the sinus cortical bone) and 2 (implant is partially
inserted into the sinus).
Case definition of peri-implantitis Peri-implantitis will be defined according to
the 2017 Word Workshop of Periodontal and Peri-implant diseases. Therefore, the
case definition applied will be as follows: presence of bleeding and/or oozing on
soft probing (∼0.2N), peri-implant probing depths of ≥6 mm, bone levels ≥3 mm
apical to the most coronal portion of the intra-osseous part of the implant
according to periapical radiography.
Morphology and severity of peri-implant bone defect The characterization of
peri-implant defects will be based on the morphology of the defect (Classes I-III)
and severity (grades L-M-A), as previously proposed. Briefly, according to
morphology it will be classified as follows Class I: infra-bony defect (Class IA:
buccal dehiscence, Class IB: 2- to 3-wall defect), Class II:
supra-crestal/horizontal defect, and Class III: combined defect (Class IIIA: buccal
dehiscence + horizontal bone loss, Class IIIB: 2- to 3-wall defect + horizontal
bone loss, Class IIIC: circumferential defect + horizontal bone loss). In terms of
severity, implants shall be classified as follows: Mild (L): 3 to 4 mm/ <25% of
implant length, Moderate (M): 4 to 5 mm/≥25% to 50% of implant length, and
Advanced(A): >6 mm/ >50% of implant length.
Statistical analysis The statistical package (SPSS 15.0, SPSS Inc., Chicago, IL,
USA, STATISTICS, version 7.1StatSoft, Inc., USA AND R 2.14.0) will be used to
analyze the data. Pearson's correlation test will be applied for the assessment of
confounding factors.
