PeriimplantitisPhase 4CHX-HANCT03142828
Implant Healing Abutment and Chlorhexidine
A Phase 4 study testing Chlorhexidine in people with Periimplantitis, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis
- What is being tested?
- Chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2017to 26 Nov 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good systemic health status (ASA I or II).
- No current pain.
- No use of painkillers or Anti-inflammatory drugs in the prior weeks.
- Older than 18 years.
- Oral hygiene index of ≤ 2 (Löe and Silness).
- A minimum of 2 mm of adhered gum.
Show all 10Show fewer
- A minimum of 8 mm of vertical bone.
- A minimum of 7 mm of vestibule-lingual bone.
- Scheduled to receive a unitary implant.
- Willing to participate in this controlled study.
Who cannot join
- Pregnant or nursing women.
- Use of any type of medication that might affect the perception of pain.
- An history of alcohol or drug abuse.
- A requirement for guided regeneration or sinus lifting procedures.
- Failure to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Application of Chlorhexidine in the Pillars of Implant Healing to Prevent Plate Accumulation. Controlled Random Blind Clinical Study.
The work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month.
Read the detailed description
Once the implants are integrated, and given the consent, the patients will be operated to connect the healing abutments as they come from the manufacturer (Mozo Grau, Ticare®). Patients will follow the study protocol in 2 arms.
The random distribution is made prior to assignment following the internet program https://www.random.org
- Conditions
- Periimplantitis
- Being tested
- Chlorhexidine, Placebo
- Keywords
- chlorhexidine, dental implant, in-situ drug delivery,
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called CHX
Healing abutment with Clorhexidine
PlaceboOther
Healing abutment without any antiseptic
| Study group | Role | What they receive |
|---|---|---|
| Test (clorhexidine gel) | Active comparator | The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants). Receives: Drug: Chlorhexidine |
| Placebo | Placebo comparator | The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of inflammation
Degree of inflammation was measured using a 4-point Likert scaleInflammation 0 = non-inflamed gingiva with pale pink color. Inflammation 1 = erythematous gingiva without bleeding on manipulation. Inflammation 2 = gingiva with slight bleeding during manipulation during unscrewing or screwing of the abutment. Inflammation 3 = gingiva with heavy bleeding during manipulation during unscrewing or screwing of the abutment.
Measured: 1 month after second surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start15 Apr 2017
- Primary completion1 Jun 2017
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the first week, the healling abutment will be randomly distributed in a test group with application of chlorhexidine gel or a control group without the application of the chlorhexidine gel.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Sánchez-Pérez, Universidad de Murcia
- Investigators
- Arturo Sánchez-Pérez, Professor, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142828
- Sponsor's protocol ID
- 1366/2016
- Acronym
- CHX-HA
- Status last verified
- Nov 2017
- First submitted
- 20 Mar 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-personal data
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Application of Chlorhexidine in the Pillars of Implant Healing to Prevent Plate Accumulation. Controlled Random Blind Clinical Study.
- ClinicalTrials.gov ID
- NCT03142828
- Acronym / sponsor ID
- CHX-HA / 1366/2016
- Conditions
- Periimplantitis
- Keywords
- chlorhexidine, dental implant, in-situ drug delivery,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 5 May 2017 (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 work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month.
Detailed description
Once the implants are integrated, and given the consent, the patients will be operated to connect the healing abutments as they come from the manufacturer (Mozo Grau, Ticare®). Patients will follow the study protocol in 2 arms.
The random distribution is made prior to assignment following the internet program https://www.random.org
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After the first week, the healling abutment will be randomly distributed in a test group with application of chlorhexidine gel or a control group without the application of the chlorhexidine gel.
| Arm | Type | Receives |
|---|---|---|
| Test (clorhexidine gel) | Active comparator | Drug: ChlorhexidineThe healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants). |
| Placebo | Placebo comparator | Other: PlaceboThe healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Good systemic health status (ASA I or II).
- No current pain.
- No use of painkillers or Anti-inflammatory drugs in the prior weeks.
- Older than 18 years.
- Oral hygiene index of ≤ 2 (Löe and Silness).
Key exclusion criteria (5 listed)
- Pregnant or nursing women.
- Use of any type of medication that might affect the perception of pain.
- An history of alcohol or drug abuse.
- A requirement for guided regeneration or sinus lifting procedures.
- Failure to comply with the study protocol.
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 |
|---|---|---|
| ChlorhexidineAlso: CHXHealing abutment with Clorhexidine | Drug | Test (clorhexidine gel) |
| PlaceboHealing abutment without any antiseptic | Other | Placebo |
Primary outcome
Degree of inflammation
Time frame: 1 month after second surgery
Degree of inflammation was measured using a 4-point Likert scaleInflammation 0 = non-inflamed gingiva with pale pink color. Inflammation 1 = erythematous gingiva without bleeding on manipulation. Inflammation 2 = gingiva with slight bleeding during manipulation during unscrewing or screwing of the abutment. Inflammation 3 = gingiva with heavy bleeding during manipulation during unscrewing or screwing of the abutment.
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 28 Nov 2017.
- Individual participant dataSharing planned: Yes. Non-personal data
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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.
Arturo Sánchez-Pérez, Professor principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine in people with Periimplantitis, run by Universidad de Murcia 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 10 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 28 Nov 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Degree of inflammation (time frame: 1 month after second surgery). 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 28 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.