Periodontal Air-Polishing Device Reduces Tissue Damage and Improves Clinical Outcomes and Exosomal Modulation. A Randomized Clinical Trial
Phase: NA
Conditions: Periodontitis
Sponsor: Universidad de Granada

Title: Periodontal Air-Polishing Device Reduces Tissue Damage, Improves 
Clinical Outcomes, and Exosomal Modulation. A Randomized Clinical Trial 
in Periodontitis Patients. 
NCT Number: Not available 
February 1st 2025 
 

PROVINCIAL BIOMEDICAL RESEARCH ETHICS COMMITTEE OF GRANADA 
(CEI GRANADA-CEIm) 
General Information 
Any researcher intending to carry out a clinical study must submit a Patient (or Participant) 
Information Sheet (P.I.S.) to the Clinical Research Ethics Committee (C.R.E.C.) together with 
the study protocol or project report. In addition, they must comply with the requirements set 
out in Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee 
of Digital Rights (Official State Gazette of 06/12/2018). 
MODEL OF PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM 
FOR STUDY PARTICIPANTS 
PATIENT OR PARTICIPANT INFORMATION SHEET (P.I.S.) 
1. Title 
of 
the 
Study: 
Periodontal Air-Polishing Device Reduces Tissue Damage, Improves Clinical 
Outcomes, and Exosomal Modulation. A Randomized Clinical Trial in Periodontitis 
Patients. 
2. Objectives: 
The aim is to compare the levels of pro- and anti-inflammatory exosomes and cytokines 
in patients treated with manual scaling and root planing versus Airflow®. 
3. Methodology: 
The study will be conducted in two phases. It is an experimental study with two 
randomized groups of patients evaluated at two time points. 
• 
First: Gingival examination prior to periodontal treatment, using a periodontal probe to 
determine bleeding, probing depth, and plaque levels. Gingival crevicular fluid will be 
collected using size 30 endodontic paper points. 
• 
Second: Repetition of the same process after manual scaling and root planing or 
Airflow®. Data will be collected at the dental units of the Faculty. 
4. Expected 
Benefits 
and 
Potential 
Risks 
of 
this 
Study: 
This study will contribute to improving knowledge of the effects of Airflow® in 
periodontal treatment compared to manual scaling and root planing. The study does not 

involve any potential risks or expected adverse reactions for the patient. Sample 
collection is completely non-invasive. 
5. Availability 
of 
Other 
Treatments 
(Alternative 
Treatments): 
The current standard treatment consists of manual scaling and root planing with 
curettes, which is included in this study. 
6. Use 
of 
Biological 
Samples: 
A sample of gingival crevicular fluid will be collected. This will be obtained using size 
30 absorbent paper points for endodontics, which will be inserted into the gingival 
sulcus for 30–40 seconds. The points will then be removed and placed in a sterile 
container for analysis. The patient will provide consent for this sample to be used only 
for the purposes described in this study. 
7. Voluntary 
Participation: 
Patient participation is voluntary. The patient may withdraw consent at any time, 
without the need to provide explanations. 
8. Confidentiality 
and 
Data 
Protection: 
Confidentiality and protection of personal data will be ensured. Only one individual, 
M.B.I., will have access to the subject’s data. 
 Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital 
Rights. The personal data requested (e.g., age, sex, health data) are necessary to meet the 
objectives of the study. In none of the study reports will your name appear, and your identity 
will not be disclosed to anyone except for the purposes of the study, or in the event of a medical 
emergency or legal requirement. Any personal information that may be identifiable will be 
stored and processed electronically under secure conditions. 
Access to such information will be restricted to authorized personnel, who will be obliged to 
maintain confidentiality. The results of the study may be communicated to health authorities 
and, eventually, to the scientific community through conferences and/or publications. 
The data will be used solely for the specific purposes of this study and, if necessary, may also 
be used for educational or scientific purposes. In accordance with current law, you have the 
right to access your personal data; likewise, if justified, you have the right to request its 
rectification or deletion. If you so wish, you must request this from the physician responsible 
for your care in this study. 

9. The amount of fluid to be collected will be 4–5 microliters, and it will be used 
exclusively for the specific purposes of the study. 
10. Any information obtained from the project that may be needed or intended for future 
use will require the patient’s information and consent. 
 
 

WRITTEN INFORMED CONSENT OF THE PATIENT OR PARTICIPANT 
Title 
of 
the 
study: 
Quantification of Cytokines and Exosomes in Gingival Crevicular Fluid by Flow Cytometry 
and Periodontal Variables in Patients Treated with Curettes and Airflow® 
I, 
(full 
name) 
........................................................................................................, 
with National ID No. …………………………… 
have spoken with the study’s responsible professional, Marco Bonilla Izquierdo, who has 
provided his contact information for any questions or clarifications regarding the study. 
Email: marcobonilla000@gmail.com 
• 
I have read the information sheet provided to me. 
• 
I have been able to ask questions about the study. 
• 
I have received sufficient information about the study. 
• 
I understand that my participation is voluntary. 
• 
I understand that I may withdraw from the study: 
1. Whenever I wish. 
2. Without having to provide explanations. 
3. Without this affecting my medical care. 
I freely give my consent to participate in the study. 
The samples obtained in this study will be used exclusively for the specific purposes of the 
study. 
Date ............................................... Signature of patient or participant 
 
 
Date ............................................... Signature of the responsible professional of the study 
and National ID No.