Wound HealingCUR_01NCT06738342
Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara
A study testing CHX 0.09% + Citrox + HA and CHX 0.12% in people with Wound Healing, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- CHX 0.09% + Citrox + HA and CHX 0.12%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- More than 20 natural teeth excluding the third molars
- Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)
- Have a full mouth plaque score (FMPS) <15% before surgery;
- Have a full mouth bleeding score (FMBS) <15% before surgery;
- Ability and willingness to give written informed consent;
- Written agreement to participate in the trial.
Who cannot join
- Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation
- Pregnancy or breastfeeding;
- Use of medication affecting the healing process;
- Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;
- Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);
- Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded.
Show all 9Show fewer
- Tobacco use (10 or more cigarettes per day)
- Inability to comply with protocol
- Uncooperative patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Sapienza University of Rome
Rome, Rome, 00161
Andrea Pilloni, andrea.pilloni@uniroma1.it
+39-0649-918152
About this study
Official title: Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara in Patients Undergoing Periodontal Surgery: a Triple-blind, Parallel-arm, Randomized Controlled Trial
The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.
- Conditions
- Wound Healing
- Being tested
- CHX 0.09% + Citrox + HA, CHX 0.12%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHX 0.09% + Citrox + HAOther
The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.
CHX 0.12%Drug
The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: CHX 0.09% + Citrox + HA |
| Control group | Active comparator | Not described Receives: Drug: CHX 0.12% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oedema
Presence of absence will be recorded (1 or 0).
Measured: 1, 3, 7 an 14 days
Secondary outcomes (5)
Early Healing Score
The score comprises three parameters (Clinical signs of re-epithelialization, hemostasis and inflammation) and ranges from 0 (worst healing) to 10 (best healing)
Measured: 24 hours post surgery, 3, 7 and 45 days post surgery
Plaque Index modified by Turesky
Measured: 1,3,7 and 14 days post surgery
Gingival Index modified by Trombelli
Measured: 1,3,7 and 14 days post surgery
Lobene Index modified
Presence of stains or discolorations of teeth and mucosae
Measured: 1,3,7 and 14 days post surgery
Adverse effects
Disgeusia, mouth ulcers
Measured: 1,3,7 and 14 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Pilloni MD DDS MS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738342
- Sponsor's protocol ID
- 0460/2022
- Acronym
- CUR_01
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara in Patients Undergoing Periodontal Surgery: a Triple-blind, Parallel-arm, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06738342
- Acronym / sponsor ID
- CUR_01 / 0460/2022
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 17 Dec 2024 (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 primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: CHX 0.09% + Citrox + HA |
| Control group | Active comparator | Drug: CHX 0.12% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- More than 20 natural teeth excluding the third molars
- Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)
- Have a full mouth plaque score (FMPS) <15% before surgery;
- Have a full mouth bleeding score (FMBS) <15% before surgery;
- Ability and willingness to give written informed consent;
Key exclusion criteria (9 listed)
- Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation
- Pregnancy or breastfeeding;
- Use of medication affecting the healing process;
- Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;
- Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);
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 |
|---|---|---|
| CHX 0.09% + Citrox + HAThe patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days. | Other | Test group |
| CHX 0.12%The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days. | Drug | Control group |
Primary outcome
Oedema
Time frame: 1, 3, 7 an 14 days
Presence of absence will be recorded (1 or 0).
5 secondary outcomes
Early Healing Score
Time frame: 24 hours post surgery, 3, 7 and 45 days post surgery
Plaque Index modified by Turesky
Time frame: 1,3,7 and 14 days post surgery
Gingival Index modified by Trombelli
Time frame: 1,3,7 and 14 days post surgery
Lobene Index modified
Time frame: 1,3,7 and 14 days post surgery
Adverse effects
Time frame: 1,3,7 and 14 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHX 0.09% + Citrox + HA and CHX 0.12% in people with Wound Healing, run by University of Roma La Sapienza 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pilloni, Professor (+39-0649-918152, andrea.pilloni@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oedema (time frame: 1, 3, 7 an 14 days). 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 20 Dec 2024.