Periodontal DiseasesCLOR_3NCT04345744
Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing
A study testing Periodontal surgery, Hyaluronic and 0.2% chlorhexidine mouth rinse and Chlorhexidine 0.2% mouth rinse in people with Periodontal Diseases and Periodontal Pocket, run by University of Pisa at 1 site in Italy.
Trial summary
Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket
- What is being tested?
- Periodontal surgery, Hyaluronic and 0.2% chlorhexidine mouth rinse and Chlorhexidine 0.2% mouth rinse
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Mar 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males or females of age range between 18 and 70 years,
- good health status,
- indication to perform periodontal surgery,
- patients willing to give informed consent,
- compliance to the study follow-up,
- plaque index (PI) score 0 and
- bleeding on probing (BOP) <25%
Who cannot join
- pregnancy or breast-feeding,
- therapy with oral contraceptives,
- indication to antibiotic therapy prior to surgical treatment,
- chronic infections,
- systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
- previous therapy with the mouth rinses employed in the present study, and
- smoking habit (>20 cigarettes per day, and/or pipe or cigar smoking).
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound.
Read the detailed description
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD) and presence of recession of the gingival margin (Rec) will be recorded on six sites/tooth in the area selected for periodontal surgery by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe at a 0.3 N probing pressure. Surgery will be performed following a standardized protocol by a single operator.
After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
The patients will be allocated in one of the three distinct study groups as it follows:
- Group A: no administration of mouth rinses after surgery (control group)
- Group B: administration of a hyaluronic and 0.2% chlorhexidine mouth rinse (test group 1)
- Group C: administration of chlorhexidine 0.2% mouth rinse (test group 2).
Post-treatment photographs of surgical incision will be taken immediately after periodontal surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Periodontal Wound Healing Index (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.
At T3, T7, and T14 the following clinical parameters will be recorded for each tooth in the surgical area: PPD, Rec, PI, and BOP. The clinical examinations will be performed by calibrated examiner blind to group allocation.
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Being tested
- Periodontal surgery, Hyaluronic and 0.2% chlorhexidine mouth rinse, Chlorhexidine 0.2% mouth rinse
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgeryProcedure or surgery
Surgery will be performed following a standardized protocol by a single operator (FG). The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.
Hyaluronic and 0.2% chlorhexidine mouth rinseDevice
The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
Chlorhexidine 0.2% mouth rinseDevice
The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | administration of a hyaluronic and 0.2% chlorhexidine mouth rinse Receives: Procedure: Periodontal surgery; Device: Hyaluronic and 0.2% chlorhexidine mouth rinse |
| Test group 2 | Experimental | administration of chlorhexidine 0.2% mouth rinse Receives: Procedure: Periodontal surgery; Device: Chlorhexidine 0.2% mouth rinse |
| Control Group | Active comparator | No administration of mouth rinses after surgery Receives: Procedure: Periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and at day 3, day 7, and day 14
Secondary outcomes (7)
Clinical attachment level (CAL)
Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and at day 3, day 7, and day 14
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and at day 3, day 7, and day 14
Bleeding on probing (BOP)
BOP, measured orally through clinical examination. Unit of measure: %
Measured: Measured at Baseline
Angulated bleeding index (AngBI)
AngBI, measured orally through clinical examination. Unit of measure: %
Measured: Measured at day 3, day 7, and day 14
Plaque index (PI)
Changes in PI, measured orally through clinical examination. Unit of measure: %
Measured: Measured at Baseline and at day 3, day 7, and day 14
Periodontal Wound Healing Index (PWHI) (Wachtel classification)
Changes in PWHI, measured orally through clinical examination on all the incisions, assigning a score from 1 to 5.
- Score 1: complete wound healing: absence of fibrin line in the interproximal area
- Score 2: complete wound healing: presence of a thin fibrin line in the interproximal area
- Score 3: complete wound healing: presence of fibrin clot in the interproximal area
- Score 4: incomplete wound healing: presence of partial necrosis of the interproximal area
- Score 5: incomplete wound healing: total necrosis of the interproximal area
Measured: Measured at day 3, day 7, and day 14
Post-surgical photographs
Post-surgical photographs will be taken and analysed after the completion of the trial
Measured: Taken at Baseline, day 3, day 7, and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study startJan 2016
- Primary completionDec 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Model description
- Single-centre randomized, parallel design, clinical trial with a 2 week follow-up
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345744
- Sponsor's protocol ID
- CLOR_3
- Acronym
- CLOR_3
- Status last verified
- Nov 2022
- First submitted
- 8 Apr 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berchier CE, Slot DE, Van der Weijden GA. The efficacy of 0.12% chlorhexidine mouthrinse compared with 0.2% on plaque accumulation and periodontal parameters: a systematic review. J Clin Periodontol. 2010 Sep;37(9):829-39. doi: 10.1111/j.1600-051X.2010.01575.x. Epub 2010 Jul 7.
PubMed 20618550
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing
- ClinicalTrials.gov ID
- NCT04345744
- Acronym / sponsor ID
- CLOR_3 / CLOR_3
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 14 Apr 2020 (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.
Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound.
Detailed description
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD) and presence of recession of the gingival margin (Rec) will be recorded on six sites/tooth in the area selected for periodontal surgery by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe at a 0.3 N probing pressure. Surgery will be performed following a standardized protocol by a single operator.
After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
The patients will be allocated in one of the three distinct study groups as it follows:
- Group A: no administration of mouth rinses after surgery (control group)
- Group B: administration of a hyaluronic and 0.2% chlorhexidine mouth rinse (test group 1)
- Group C: administration of chlorhexidine 0.2% mouth rinse (test group 2).
Post-treatment photographs of surgical incision will be taken immediately after periodontal surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Periodontal Wound Healing Index (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.
At T3, T7, and T14 the following clinical parameters will be recorded for each tooth in the surgical area: PPD, Rec, PI, and BOP. The clinical examinations will be performed by calibrated examiner blind to group allocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-centre randomized, parallel design, clinical trial with a 2 week follow-up
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Procedure: Periodontal surgery, Device: Hyaluronic and 0.2% chlorhexidine mouth rinseadministration of a hyaluronic and 0.2% chlorhexidine mouth rinse |
| Test group 2 | Experimental | Procedure: Periodontal surgery, Device: Chlorhexidine 0.2% mouth rinseadministration of chlorhexidine 0.2% mouth rinse |
| Control Group | Active comparator | Procedure: Periodontal surgeryNo administration of mouth rinses after surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- males or females of age range between 18 and 70 years,
- good health status,
- indication to perform periodontal surgery,
- patients willing to give informed consent,
- compliance to the study follow-up,
Key exclusion criteria (7 listed)
- pregnancy or breast-feeding,
- therapy with oral contraceptives,
- indication to antibiotic therapy prior to surgical treatment,
- chronic infections,
- systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
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 |
|---|---|---|
| Periodontal surgerySurgery will be performed following a standardized protocol by a single operator (FG). The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision. | Procedure or surgery | Control Group, Test group 1, Test group 2 |
| Hyaluronic and 0.2% chlorhexidine mouth rinseThe mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days. | Device | Test group 1 |
| Chlorhexidine 0.2% mouth rinseThe mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days. | Device | Test group 2 |
Primary outcome
Pocket probing depth (PPD)
Time frame: Measured at Baseline and at day 3, day 7, and day 14
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
7 secondary outcomes
Clinical attachment level (CAL)
Time frame: Measured at Baseline and at day 3, day 7, and day 14
Recession of the gingival margin (REC)
Time frame: Measured at Baseline and at day 3, day 7, and day 14
Bleeding on probing (BOP)
Time frame: Measured at Baseline
Angulated bleeding index (AngBI)
Time frame: Measured at day 3, day 7, and day 14
Plaque index (PI)
Time frame: Measured at Baseline and at day 3, day 7, and day 14
Periodontal Wound Healing Index (PWHI) (Wachtel classification)
Time frame: Measured at day 3, day 7, and day 14
Post-surgical photographs
Time frame: Taken at Baseline, day 3, day 7, and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Results publication: PubMed 20618550Berchier CE, Slot DE, Van der Weijden GA. The efficacy of 0.12% chlorhexidine mouthrinse compared with 0.2% on plaque accumulation and periodontal parameters: a systematic review. J Clin Periodontol. 2010 Sep;37(9):829-39. doi: 10.1111/j.1600-051X.2010.01575.x. Epub 2010 Jul 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal surgery, Hyaluronic and 0.2% chlorhexidine mouth rinse and Chlorhexidine 0.2% mouth rinse in people with Periodontal Diseases and Periodontal Pocket, run by University of Pisa 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 7 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket probing depth (PPD) (time frame: Measured at Baseline and at day 3, day 7, and day 14). 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 NCT04345744, which also lists 1 linked publication.
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 7 Nov 2022.