Peri-implant MucositisNCT03533166
Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis
A study testing Chlorhexidine in people with Peri-implant Mucositis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2015to 7 Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading)
Who cannot join
- untreated or recurrent periodontitis [presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) > 25%];
- implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss);
- removable implant-retained prosthesis;
- history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes;
- and women being pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Effects of a 0.03% Chlorhexidine Mouth Rinse in the Prevention of Peri-implant Diseases: a Randomized Clinical Trial
Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis.
Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.
- Conditions
- Peri-implant Mucositis
- Being tested
- Chlorhexidine, Placebo
- Keywords
- Peri-implant mucositis, Chlorhexidine, CPC, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineOther
0.03% Chlorhexidine + 0.05% CPC mouth rinse
PlaceboOther
Placebo mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse Receives: Other: Chlorhexidine |
| Placebo | Placebo comparator | Mechanical treatment + Placebo mouth rinse Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on bleeding on probing on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. Primary outcome would be considered for the change between baseline and 12 months
One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Measured: Change baseline-12 months
Secondary outcomes (44)
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months.
One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Measured: Baseline
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months.
One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Measured: 3 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months.
One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Measured: 6 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months.
One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Measured: 9 months
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months.
One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Measured: 12 months
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing
One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: Baseline
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing
One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 6 months
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing
One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 12 months
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987):
- Score 0: no plaque detected;
- Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant;
- Score 2: plaque can be seen by the naked eye;
- Score 3: abundance of soft matter.
One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA).
Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Measured: Baseline
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987):
- Score 0: no plaque detected;
- Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant;
- Score 2: plaque can be seen by the naked eye;
- Score 3: abundance of soft matter.
One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA).
Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Measured: 6 months
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987):
- Score 0: no plaque detected;
- Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant;
- Score 2: plaque can be seen by the naked eye;
- Score 3: abundance of soft matter.
One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA).
Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Measured: 12 months
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth
- Score 0: no plaque detected;
- Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth
- Score 2: plaque can be seen by the naked eye;
- Score 3: abundance of soft matter.
One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: Baseline
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth
- Score 0: no plaque detected;
- Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth
- Score 2: plaque can be seen by the naked eye;
- Score 3: abundance of soft matter.
One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 6 months
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth
- Score 0: no plaque detected;
- Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth
- Score 2: plaque can be seen by the naked eye;
- Score 3: abundance of soft matter.
One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 12 months
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant).
One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Measured: Baseline
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant).
One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Measured: 6 months
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant).
One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA)
Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Measured: 12 months
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth).
One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: Baseline
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth).
One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 6 months
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth).
One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 12 months
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site.
One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA).
Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Measured: Baseline
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site.
One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA).
Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Measured: 6 months
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site.
One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA).
Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Measured: 12 months
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction.
One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: Baseline
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction.
One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 6 months
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction.
One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Measured: 12 months
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient.
Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed \& Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media.
Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Measured: Baseline
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient.
Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed \& Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media.
Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Measured: 6 months
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient.
Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed \& Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media.
Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Measured: 12 months
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Measured: Baseline
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Measured: 6 months
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Measured: 12 months
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Measured: Baseline
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Measured: 6 months
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Measured: 12 months
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL).
Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image).
After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Measured: Baseline
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL).
Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image).
After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Measured: 3 months
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL).
Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image).
After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Measured: 12 months
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Measured: Baseline
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Measured: 6 months
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Measured: 12 months
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Measured: Baseline
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Measured: 6 months
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start4 Nov 2015
- Primary completion25 Mar 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Dentaid SL
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz, Doctor, Principal investigator, University Complutense Madrid (UCM)David Herrera, Doctor, Principal investigator, University Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533166
- Sponsor's protocol ID
- 15/064
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bollain J, Pulcini A, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Efficacy of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in reducing inflammation around the teeth and implants: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1729-1741. doi: 10.1007/s00784-020-03474-3. Epub 2020 Jul 31.
PubMed 32737664Pulcini A, Bollain J, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Clinical effects of the adjunctive use of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in the management of peri-implant diseases: A randomized clinical trial. J Clin Periodontol. 2019 Mar;46(3):342-353. doi: 10.1111/jcpe.13088.
PubMed 30779246
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Effects of a 0.03% Chlorhexidine Mouth Rinse in the Prevention of Peri-implant Diseases: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03533166
- Acronym / sponsor ID
- 15/064
- Conditions
- Peri-implant Mucositis
- Keywords
- Peri-implant mucositis, Chlorhexidine, CPC, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Dentaid SL
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 25 Mar 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 23 May 2018 (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.
Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis.
Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Other: ChlorhexidineMechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse |
| Placebo | Placebo comparator | Other: PlaceboMechanical treatment + Placebo mouth rinse |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading)
Key exclusion criteria (5 listed)
- untreated or recurrent periodontitis [presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) > 25%];
- implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss);
- removable implant-retained prosthesis;
- history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes;
- and women being pregnant or breast-feeding.
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 |
|---|---|---|
| Chlorhexidine0.03% Chlorhexidine + 0.05% CPC mouth rinse | Other | Chlorhexidine |
| PlaceboPlacebo mouth rinse | Other | Placebo |
Primary outcome
Change on bleeding on probing on implants
Time frame: Change baseline-12 months
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. Primary outcome would be considered for the change between baseline and 12 months One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
44 secondary outcomes
Bleeding on probing (BOP) on implants
Time frame: Baseline
Bleeding on probing (BOP) on implants
Time frame: 3 months
Bleeding on probing (BOP) on implants
Time frame: 6 months
Bleeding on probing (BOP) on implants
Time frame: 9 months
Bleeding on probing (BOP) on implants
Time frame: 12 months
Bleeding on probing (BOP) on teeth
Time frame: Baseline
Bleeding on probing (BOP) on teeth
Time frame: 6 months
Bleeding on probing (BOP) on teeth
Time frame: 12 months
Plaque on implants
Time frame: Baseline
Plaque on implants
Time frame: 6 months
Plaque on implants
Time frame: 12 months
Plaque on teeth
Time frame: Baseline
Plaque on teeth
Time frame: 6 months
Plaque on teeth
Time frame: 12 months
Probing depth on implants
Time frame: Baseline
Probing depth on implants
Time frame: 6 months
Probing depth on implants
Time frame: 12 months
Probing depth on teeth
Time frame: Baseline
Probing depth on teeth
Time frame: 6 months
Probing depth on teeth
Time frame: 12 months
Crown-length implant
Time frame: Baseline
Crown-length implant
Time frame: 6 months
Crown-length implant
Time frame: 12 months
Recession on teeth
Time frame: Baseline
Recession on teeth
Time frame: 6 months
Recession on teeth
Time frame: 12 months
Microbiological outcomes_total counts
Time frame: Baseline
Microbiological outcomes_total counts
Time frame: 6 months
Microbiological outcomes_total counts
Time frame: 12 months
Microbiological outcomes_frequency of detection
Time frame: Baseline
Microbiological outcomes_frequency of detection
Time frame: 6 months
Microbiological outcomes_frequency of detection
Time frame: 12 months
Microbiological outcomes_proportions
Time frame: Baseline
Microbiological outcomes_proportions
Time frame: 6 months
Microbiological outcomes_proportions
Time frame: 12 months
Radiographic bone loss on implants
Time frame: Baseline
Radiographic bone loss on implants
Time frame: 3 months
Radiographic bone loss on implants
Time frame: 12 months
Staining
Time frame: Baseline
Staining
Time frame: 6 months
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 23 May 2018.
- Derived from this study: PubMed 32737664Bollain J, Pulcini A, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Efficacy of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in reducing inflammation around the teeth and implants: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1729-1741. doi: 10.1007/s00784-020-03474-3. Epub 2020 Jul 31.
- Derived from this study: PubMed 30779246Pulcini A, Bollain J, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Clinical effects of the adjunctive use of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in the management of peri-implant diseases: A randomized clinical trial. J Clin Periodontol. 2019 Mar;46(3):342-353. doi: 10.1111/jcpe.13088.
- Individual participant dataSharing planned: No
Related trials for Peri-implant Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruitingObservational study
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
Peri-Implant Mucositis
RecruitingObservational study
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Peri-Implant Health, Peri Implant Mucositis
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.
Mariano Sanz, Doctor principal investigator
University Complutense Madrid (UCM)
David Herrera, Doctor principal investigator
University Complutense Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine in people with Peri-implant Mucositis, run by Universidad Complutense de Madrid at 1 site in Spain.
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 1 inclusion and 5 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 23 May 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Change on bleeding on probing on implants (time frame: Change baseline-12 months). 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 NCT03533166, which also lists 2 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 23 May 2018.