Pregnancy GingivitisNCT04140643
Ozone Therapy for the Home Oral Hygiene of the Pregnant Woman.
A study testing Ozonated water delivering device effects on the oral health of pregnant women and Oral hygiene instructions in people with Pregnancy Gingivitis and Ozone, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The aim of the present study is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women. Two groups of 30 women will be enrolled following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device and a control… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Gingivitis, Ozone
- What is being tested?
- Ozonated water delivering device effects on the oral health of pregnant women and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Dec 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- legal age
- pregnancy period between the 14 and 30 week
- diagnosis positive for pregnancy gingivitis
- presence of at least 20 teeth
Who cannot join
- absumption of alcohol during pregnancy
- systemic diseases
- chronic drug assumption
- allergies
- ongoing orthodontic therapies
- positive periodontal screening recording (PSR) at T1
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dental Clinic, IRCCS San Raffaele Hospital
Milan, MI, 20132
Simona Tecco, DDS, MS, PhD, +39 3297838023, tecco.simona@hsr.it
Simona Tecco, DDS, MS, PhD
About this study
Official title: Ozone Therapy as an Aid for Home Oral Hygiene. The Use of Aquolab in the Pregnant Woman.
The aim of the present study is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women.
Two groups of 30 women will be enrolled following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device and a control group B that will not be equipped with the device. The sample size was calculated with a power analysis performed starting from descriptive data differences obtained from a pilot study in order to achieve a power higher than 80 percent with an alpha error of 0.05 resulting in a minimum of 27 participants for each group.
Read more
The protocol was in accordance with the Declaration of Helsinki and was approved by the Ethical Committee of the IRCCS San Raffaele Hospital, all the participants will be informed about the aim of the study and will sign an informed consent form.
At the first examination (T0) the clinical oral hygiene parameters will be recorded on the enrolled participants of both the groups and they will be subjected to a professional oral hygiene procedure with appropriate home oral hygiene instructions. The same clinical oral hygiene parameters will be recorded also after 15 days (T1) and after 75 days (T2) from the first examination.
All the clinical procedures and data recording will be conducted by the operator X blind to the participants group while the operator Y will give the device and instruct the participants to its proper use.
After a descriptive analysis of the data, an analysis of the data distribution will be performed with the Kolmogorov-Smirnov test. According with the result of the data distribution analysis the differences between-groups and within-groups will be evaluated with the proper parametric or non-parametric test.
Read the detailed description
The aim of the present study is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women.
In the present study a total of 60 pregnant women will be recruited at the dental clinic of the IRCCS San Raffaele Hospital. These participants must adhere to the following inclusion criteria: legal age, pregnancy period between the 14 and 30 week, diagnosis positive for pregnancy gingivitis, presence of at least 20 teeth. The following exclusion criteria will be applied: absumption of alcohol during pregnancy, systemic diseases, chronic drug assumption, allergies, ongoing orthodontic therapies, positive periodontal screening recording (PSR).
The participants will be assigned to two groups following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device (Aquolab®, EB2C, Milan, Italy) and a control group B that will not be equipped with the device. The sample size was calculated with a power analysis performed starting from descriptive data differences obtained from a pilot study in order to achieve a power higher than 80 percent with an alpha error of 0.05 resulting in a minimum of 27 participants for each group. A total of 30 subjects will be assigned to each group in order to prevent possible drop-outs.
The protocol was in accordance with the Declaration of Helsinki and was approved by the Ethical Committee of the IRCCS San Raffaele Hospital, all the participants will be informed about the aim of the study and will sign an informed consent form.
At the first examination (T0) the clinical oral hygiene parameters will be recorded on the enrolled participants of both the groups and they will be subjected to a professional oral hygiene procedure with appropriate home oral hygiene instructions. The same clinical oral hygiene parameters will be recorded also after 15 days (T1) and after 75 days (T2) from the first examination.
All the clinical procedures and data recording will be conducted by the operator X blind to the participants group while the operator Y will give the device and instruct the participants to its proper use.
After a descriptive analysis of the data, an analysis of the data distribution will be performed with the Kolmogorov-Smirnov test. According with the result of the data distribution analysis the differences between-groups and within-groups will be evaluated with the proper parametric or non-parametric test.
- Conditions
- Pregnancy Gingivitis, Ozone
- Being tested
- Ozonated water delivering device effects on the oral health of pregnant women, Oral hygiene instructions
- Keywords
- Pregnancy, Oral Health, Ozone therapy, Gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated water delivering device effects on the oral health of pregnant womenDevice
Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.
Oral hygiene instructionsBehavioural
Oral Hygiene instructions
| Study group | Role | What they receive |
|---|---|---|
| Ozone therapy | Experimental | Oral hygiene instructions given by dental hygienist and home daily use of ozonated water delivering system. Receives: Device: Ozonated water delivering device effects on the oral health of pregnant women |
| Only oral hygiene instructions | Active comparator | Oral hygiene instructions given by dental hygienist. Receives: Behavioral: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Screening Recording (PSR)
Code 0 - Colored area of probe remains completely visible in the deepest crevice in the sextant. No calculus or defective margins are detected. Gingival tissues are healthy with no bleeding after gentle probing.
- Code 1 - Colored area of probe remains completely visible in the deepest probing depth in the sextant. No calculus or margins are detected. There is bleeding after gentle probing.
- Code 2 - Colored area of probe remains completely visible in the deepest probing depth in the sextant. Supra- or subgingival calculus and/or defective margins are detected.
Code 3 - Colored area of probe remains partly visible in the deepest probing depth in the sextant.
- Code 4 - Colored area of probe completely disappears, indicating probing depth of greater than 5.5 mm.
Measured: 60 Days
Secondary outcomes (3)
Bleeding of Probing (BOP)
Expressed as Full Mouth Bleeding Score (FMPS), percentage of bleeding sites on the total number of available sites.
Measured: 60 Days
Plaque Index (PI)
Expressed as Full Mouth Plaque Score (FMPS), percentage of plaque containing dental surfaces on the total number of available surfaces.
Measured: 60 Days
Probing Depth (PD)
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Mar 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy GingivitisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Tecco, IRCCS San Raffaele
- Investigators
- Enrico Gherlone, MD, MS, Study chair, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140643
- Sponsor's protocol ID
- EB2C
- Status last verified
- Jul 2020
- First submitted
- 3 May 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Geisinger ML, Geurs NC, Bain JL, Kaur M, Vassilopoulos PJ, Cliver SP, Hauth JC, Reddy MS. Oral health education and therapy reduces gingivitis during pregnancy. J Clin Periodontol. 2014 Feb;41(2):141-8. doi: 10.1111/jcpe.12188. Epub 2013 Nov 19.
PubMed 24164645Jiang H, Xiong X, Buekens P, Su Y, Qian X. Use of mouth rinse during pregnancy to improve birth and neonatal outcomes: a randomized controlled trial. BMC Pregnancy Childbirth. 2015 Nov 25;15:311. doi: 10.1186/s12884-015-0761-3.
PubMed 26608342Villa A, Abati S, Pileri P, Calabrese S, Capobianco G, Strohmenger L, Ottolenghi L, Cetin I, Campus GG. Oral health and oral diseases in pregnancy: a multicentre survey of Italian postpartum women. Aust Dent J. 2013 Jun;58(2):224-9. doi: 10.1111/adj.12058. Epub 2013 May 5.
PubMed 23713644Almerich-Silla JM, Alminana-Pastor PJ, Boronat-Catala M, Bellot-Arcis C, Montiel-Company JM. Socioeconomic factors and severity of periodontal disease in adults (35-44 years). A cross sectional study. J Clin Exp Dent. 2017 Aug 1;9(8):e988-e994. doi: 10.4317/jced.54033. eCollection 2017 Aug.
PubMed 28936289Tecco S, Nota A, D'Amicantonio T, Pittari L, Monti M, Polizzi E. Effects of an Ozonated Water Irrigator on the Plaque Index and Bleeding Index of Pregnant Women. J Clin Med. 2022 Jul 15;11(14):4107. doi: 10.3390/jcm11144107.
PubMed 35887871
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozone Therapy as an Aid for Home Oral Hygiene. The Use of Aquolab in the Pregnant Woman.
- ClinicalTrials.gov ID
- NCT04140643
- Acronym / sponsor ID
- EB2C
- Conditions
- Pregnancy Gingivitis, Ozone
- Keywords
- Pregnancy, Oral Health, Ozone therapy, Gingivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 28 Oct 2019 (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 is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women.
Two groups of 30 women will be enrolled following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device and a control group B that will not be equipped with the device. The sample size was calculated with a power analysis performed starting from descriptive data differences obtained from a pilot study in order to achieve a power higher than 80 percent with an alpha error of 0.05 resulting in a minimum of 27 participants for each group.
The protocol was in accordance with the Declaration of Helsinki and was approved by the Ethical Committee of the IRCCS San Raffaele Hospital, all the participants will be informed about the aim of the study and will sign an informed consent form.
At the first examination (T0) the clinical oral hygiene parameters will be recorded on the enrolled participants of both the groups and they will be subjected to a professional oral hygiene procedure with appropriate home oral hygiene instructions. The same clinical oral hygiene parameters will be recorded also after 15 days (T1) and after 75 days (T2) from the first examination.
All the clinical procedures and data recording will be conducted by the operator X blind to the participants group while the operator Y will give the device and instruct the participants to its proper use.
After a descriptive analysis of the data, an analysis of the data distribution will be performed with the Kolmogorov-Smirnov test. According with the result of the data distribution analysis the differences between-groups and within-groups will be evaluated with the proper parametric or non-parametric test.
Detailed description
The aim of the present study is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women.
In the present study a total of 60 pregnant women will be recruited at the dental clinic of the IRCCS San Raffaele Hospital. These participants must adhere to the following inclusion criteria: legal age, pregnancy period between the 14 and 30 week, diagnosis positive for pregnancy gingivitis, presence of at least 20 teeth. The following exclusion criteria will be applied: absumption of alcohol during pregnancy, systemic diseases, chronic drug assumption, allergies, ongoing orthodontic therapies, positive periodontal screening recording (PSR).
The participants will be assigned to two groups following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device (Aquolab®, EB2C, Milan, Italy) and a control group B that will not be equipped with the device. The sample size was calculated with a power analysis performed starting from descriptive data differences obtained from a pilot study in order to achieve a power higher than 80 percent with an alpha error of 0.05 resulting in a minimum of 27 participants for each group. A total of 30 subjects will be assigned to each group in order to prevent possible drop-outs.
The protocol was in accordance with the Declaration of Helsinki and was approved by the Ethical Committee of the IRCCS San Raffaele Hospital, all the participants will be informed about the aim of the study and will sign an informed consent form.
At the first examination (T0) the clinical oral hygiene parameters will be recorded on the enrolled participants of both the groups and they will be subjected to a professional oral hygiene procedure with appropriate home oral hygiene instructions. The same clinical oral hygiene parameters will be recorded also after 15 days (T1) and after 75 days (T2) from the first examination.
All the clinical procedures and data recording will be conducted by the operator X blind to the participants group while the operator Y will give the device and instruct the participants to its proper use.
After a descriptive analysis of the data, an analysis of the data distribution will be performed with the Kolmogorov-Smirnov test. According with the result of the data distribution analysis the differences between-groups and within-groups will be evaluated with the proper parametric or non-parametric test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone therapy | Experimental | Device: Ozonated water delivering device effects on the oral health of pregnant womenOral hygiene instructions given by dental hygienist and home daily use of ozonated water delivering system. |
| Only oral hygiene instructions | Active comparator | Behavioral: Oral hygiene instructionsOral hygiene instructions given by dental hygienist. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- legal age
- pregnancy period between the 14 and 30 week
- diagnosis positive for pregnancy gingivitis
- presence of at least 20 teeth
Key exclusion criteria (6 listed)
- absumption of alcohol during pregnancy
- systemic diseases
- chronic drug assumption
- allergies
- ongoing orthodontic therapies
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 |
|---|---|---|
| Ozonated water delivering device effects on the oral health of pregnant womenOral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days. | Device | Ozone therapy |
| Oral hygiene instructionsOral Hygiene instructions | Behavioural | Only oral hygiene instructions |
Primary outcome
Periodontal Screening Recording (PSR)
Time frame: 60 Days
Code 0 - Colored area of probe remains completely visible in the deepest crevice in the sextant. No calculus or defective margins are detected. Gingival tissues are healthy with no bleeding after gentle probing. * Code 1 - Colored area of probe remains completely visible in the deepest probing depth in the sextant. No calculus or margins are detected. There is bleeding after gentle probing. * Code 2 - Colored area of probe remains completely visible in the deepest probing depth in the sextant. Supra- or subgingival calculus and/or defective margins are detected. Code 3 - Colored area of probe remains partly visible in the deepest probing depth in the sextant. • Code 4 - Colored area of probe completely disappears, indicating probing depth of greater than 5.5 mm.
3 secondary outcomes
Bleeding of Probing (BOP)
Time frame: 60 Days
Plaque Index (PI)
Time frame: 60 Days
Probing Depth (PD)
Time frame: 60 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 24164645Geisinger ML, Geurs NC, Bain JL, Kaur M, Vassilopoulos PJ, Cliver SP, Hauth JC, Reddy MS. Oral health education and therapy reduces gingivitis during pregnancy. J Clin Periodontol. 2014 Feb;41(2):141-8. doi: 10.1111/jcpe.12188. Epub 2013 Nov 19.
- Background: PubMed 26608342Jiang H, Xiong X, Buekens P, Su Y, Qian X. Use of mouth rinse during pregnancy to improve birth and neonatal outcomes: a randomized controlled trial. BMC Pregnancy Childbirth. 2015 Nov 25;15:311. doi: 10.1186/s12884-015-0761-3.
- Background: PubMed 23713644Villa A, Abati S, Pileri P, Calabrese S, Capobianco G, Strohmenger L, Ottolenghi L, Cetin I, Campus GG. Oral health and oral diseases in pregnancy: a multicentre survey of Italian postpartum women. Aust Dent J. 2013 Jun;58(2):224-9. doi: 10.1111/adj.12058. Epub 2013 May 5.
- Background: PubMed 28936289Almerich-Silla JM, Alminana-Pastor PJ, Boronat-Catala M, Bellot-Arcis C, Montiel-Company JM. Socioeconomic factors and severity of periodontal disease in adults (35-44 years). A cross sectional study. J Clin Exp Dent. 2017 Aug 1;9(8):e988-e994. doi: 10.4317/jced.54033. eCollection 2017 Aug.
- Derived from this study: PubMed 35887871Tecco S, Nota A, D'Amicantonio T, Pittari L, Monti M, Polizzi E. Effects of an Ozonated Water Irrigator on the Plaque Index and Bleeding Index of Pregnant Women. J Clin Med. 2022 Jul 15;11(14):4107. doi: 10.3390/jcm11144107.
- Individual participant dataSharing planned: Undecided
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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.
Enrico Gherlone, MD, MS study chair
IRCCS San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated water delivering device effects on the oral health of pregnant women and Oral hygiene instructions in people with Pregnancy Gingivitis and Ozone, run by IRCCS San Raffaele 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 4 inclusion and 6 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 29 Jul 2020. 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. 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 Simona Tecco, DDS, MS, PhD (+39 3297838023, tecco.simona@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Screening Recording (PSR) (time frame: 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140643, which also lists 5 linked publications.
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 29 Jul 2020.