Peri-ImplantitisPhase 4NCT03157193
Effect of Hyaluronic Acid on Perimplantitis
A Phase 4 study testing Hyaluronic Acid and Hydroxypropyl Guar in people with Peri-Implantitis, run by Universidad de Granada.
Trial summary
The effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Hyaluronic Acid and Hydroxypropyl Guar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implants with at least one year of functional load.
- Implants diagnosed with peri-implantitis according to the criteria of the Association of Dental Implantology.
Who cannot join
- Previous peri-implantitis treatment.
- Pregnancy or breast-feeding.
- Neoplastic disease.
- Antibiotic treatment during the previous month.
About this study
Official title: Effect of Hyaluronic Acid on Peri-implant Pathology: A Double-blind, Randomized, Controlled Clinical Trial.
The effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.
Read the detailed description
The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.
A randomized, controlled, double-blind clinical trial was designed on 100 perimplantitis affected implants placed in 61 subjects. Inclusion criteria were implants with at least 1 year of functional loading and with diagnosis of perimplantitis following the criteria from the Association of Dental Implantology. All implant received perimplantitis treatment. Each patient was randomly assigned to receive a gel containing 0.8% HA (Test group), a gel without HA (Placebo group) or no gel treatment (Control group). After a first gel application at baseline, test and placebo patients performed gel applications at home 3 times/day for 45 days. Clinical variables of each implant were recorded at baseline, 45 and 90 days (probing depth, attachment loss, bleeding). Intraoral radiographs of each implants were performed to measure marginal bone level. Peri-implant crevicular fluid was collected from each implant at baseline and after 45 days of treatment, to assess IL-1β and TNFα levels by ELISA technique. Clustering analysis, considering multiple implants within each patient, was performed.
- Conditions
- Peri-Implantitis
- Being tested
- Hyaluronic Acid, Hydroxypropyl Guar
- Keywords
- Peri-Implantitis, Dental Implants, Hyaluronic Acid, Clinical Trial
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Also called HA
Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
Hydroxypropyl GuarDrug
Also called Control 1
Hydroxypropyl Guar gel application as sham comparator
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days. Receives: Drug: Hyaluronic Acid |
| Control 1 Group | Sham comparator | Hydroxypropyl guar based gel, without any biological effect. Receives: Drug: Hydroxypropyl Guar |
| Control 2 Group | No intervention | No gel application, only standard perimplantitis treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant probing depth
Probing depth (mm) assessed by periodontal probe.
Measured: Baseline, change at 45 days and at 90 days.
Peri-implant attachment level
Probing attachment level (mm) calculated using probing depth and exposed implant threads.
Measured: Baseline, change at 45 days and at 90 days.
Peri-implant bleeding
Bleeding on probing expressed as % of bleeding implants in each group.
Measured: Baseline, change at 45 days and at 90 days.
Marginal Bone level
Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).
Measured: Baseline, change at 45 days and at 90 days.
Peri-implant crevicular fluid cytokines.
Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.
Measured: Baseline and change at 45 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startSep 2014
- Primary completionJan 2016
- Study completionDec 2016
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 Peri-ImplantitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Ricerfarma S.r.l
- Responsible party
- Principal investigator, Francisco Mesa, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157193
- Sponsor's protocol ID
- OTRI-3300
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
PubMed 33634616
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronic Acid on Peri-implant Pathology: A Double-blind, Randomized, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03157193
- Acronym / sponsor ID
- OTRI-3300
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implantitis, Dental Implants, Hyaluronic Acid, Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Ricerfarma S.r.l
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 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 effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.
Detailed description
The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.
A randomized, controlled, double-blind clinical trial was designed on 100 perimplantitis affected implants placed in 61 subjects. Inclusion criteria were implants with at least 1 year of functional loading and with diagnosis of perimplantitis following the criteria from the Association of Dental Implantology. All implant received perimplantitis treatment. Each patient was randomly assigned to receive a gel containing 0.8% HA (Test group), a gel without HA (Placebo group) or no gel treatment (Control group). After a first gel application at baseline, test and placebo patients performed gel applications at home 3 times/day for 45 days. Clinical variables of each implant were recorded at baseline, 45 and 90 days (probing depth, attachment loss, bleeding). Intraoral radiographs of each implants were performed to measure marginal bone level. Peri-implant crevicular fluid was collected from each implant at baseline and after 45 days of treatment, to assess IL-1β and TNFα levels by ELISA technique. Clustering analysis, considering multiple implants within each patient, was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Hyaluronic AcidHyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days. |
| Control 1 Group | Sham comparator | Drug: Hydroxypropyl GuarHydroxypropyl guar based gel, without any biological effect. |
| Control 2 Group | No intervention | –No gel application, only standard perimplantitis treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Implants with at least one year of functional load.
- Implants diagnosed with peri-implantitis according to the criteria of the Association of Dental Implantology.
Key exclusion criteria (4 listed)
- Previous peri-implantitis treatment.
- Pregnancy or breast-feeding.
- Neoplastic disease.
- Antibiotic treatment during the previous month.
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 |
|---|---|---|
| Hyaluronic AcidAlso: HAHyaluronic acid gel application as coadjuvant in the treatment of perimplantitis. | Drug | Test Group |
| Hydroxypropyl GuarAlso: Control 1Hydroxypropyl Guar gel application as sham comparator | Drug | Control 1 Group |
Primary outcome
Peri-implant probing depth
Time frame: Baseline, change at 45 days and at 90 days.
Probing depth (mm) assessed by periodontal probe.
Peri-implant attachment level
Time frame: Baseline, change at 45 days and at 90 days.
Probing attachment level (mm) calculated using probing depth and exposed implant threads.
Peri-implant bleeding
Time frame: Baseline, change at 45 days and at 90 days.
Bleeding on probing expressed as % of bleeding implants in each group.
Marginal Bone level
Time frame: Baseline, change at 45 days and at 90 days.
Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).
Peri-implant crevicular fluid cytokines.
Time frame: Baseline and change at 45 days.
Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.
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 17 May 2017.
- Derived from this study: PubMed 33634616Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic Acid and Hydroxypropyl Guar in people with Peri-Implantitis, run by Universidad de Granada.
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 2 inclusion and 4 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Peri-implant probing depth (time frame: Baseline, change at 45 days and at 90 days.). The study lists 5 primary outcomes in all. 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 NCT03157193, 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 17 May 2017.