Peri-ImplantitisNCT04874467
Influence of Keratinized Mucosa on Dental Implants With Mucositis
A study testing Supportive periodontal therapy in people with Peri-Implantitis and Peri-implant Mucositis, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Introduction: It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present. There is still controversy on which factors can be considered as risk indicators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Compliance, Patient
- What is being tested?
- Supportive periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 25 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients> 18 years;
- smokers <10 cigarettes / day;
- partially edentulous patients. The spaces must be associated with at least one adjacent mesial and one distal tooth;
- presence of bleeding and / or suppuration on probing, erythema and inflammation;
- absence of radiographic bone loss around implant distance (<2mm from expected radiographic marginal bone level);
- individual dental implants rehabilitated for more than a year;
Show all 10Show fewer
- screw-retained restorations on implants;
- absence of active periodontal disease;
- who have not taken systemic antibiotics in the last 3 months;
- adequate oral hygiene motivation and collaboration defined as plaque index <25%
Who cannot join
- totally edentulous patients;
- uncontrolled systemic diseases;
- diseases of the mucosa (erosive lichen planus, etc.);
- taking medications that may interfere with periodontal health or healing; (corticosteroids, calcium channel antagonists, antiepileptic drugs, immunosuppressants, etc.)
- pregnant or lactating patients;
- cemented implant restorations;
- restorations on implants over contoured that cannot be corrected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Keratinized Mucosa on Dental Implants With Mucositis in Patients Undergoing Supportive Periodontal Therapy
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
Read more
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM < 2 mm.
Material and methods:
38 patients presenting one single implant each with a single screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.
A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.
Read the detailed description
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM < 2 mm.
Methods:
38 patients presenting one single implant each with a screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.
A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.
- Being tested
- Supportive periodontal therapy
- Medical subject headings
- Peri-Implantitis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive periodontal therapyProcedure or surgery
A complete professional prophylaxis session will be performed, which includes ultrasound debridement, scaling with curettes and dental polishing with a rubber cup. On the other hand, in implants affected by mucositis, supra and sub-gingival debridement will be performed using a combination of ultrasound with a titanium tip and titanium curettes.
All patients will receive personalized hygiene instructions. Patients will be instructed to brush their implants twice daily using the modified Bass technique with a medium-hard manual toothbrush and low-abrasive toothpaste. In addition, they will be taught to use specific interproximal brushes. If access with an interdental brush is not possible, flossing will be indicated. Oral hygiene instructions will be reviewed at each visit.
| Study group | Role | What they receive |
|---|---|---|
| Keratinized Mucosa ≥ 2 mm | Experimental | Supportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions Receives: Procedure: Supportive periodontal therapy |
| Keratinized Mucosa < 2 mm | Experimental | Supportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions Receives: Procedure: Supportive periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
The main objective of the study is to evaluate the association between MQ and recurrence of mucositis, comparing the bleeding index on probing (BoP) in implants that have mucositis, in a control group characterized by 2 mm or more of MQ and a test group characterized by less than 2 mm of MQ over a 24-week period after peri-implant maintenance therapy.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Sep 2020
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
- Investigators
- Jose Nart, DDS PhD, Study chair, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874467
- Sponsor's protocol ID
- PER-ECL-2020-02
- Status last verified
- Aug 2022
- First submitted
- 30 Apr 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blasi G, Chierico F, Amerio E, Alvarez G, Isabal S, Arredondo A, Blanc V, Nart J, Monje A. Influence of keratinized mucosa width on the resolution of peri-implant mucositis: A prospective cohort study. Clin Implant Dent Relat Res. 2024 Jun;26(3):581-591. doi: 10.1111/cid.13317. Epub 2024 Mar 1.
PubMed 38426741
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Keratinized Mucosa on Dental Implants With Mucositis in Patients Undergoing Supportive Periodontal Therapy
- ClinicalTrials.gov ID
- NCT04874467
- Acronym / sponsor ID
- PER-ECL-2020-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 5 May 2021 (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.
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM < 2 mm.
Material and methods:
38 patients presenting one single implant each with a single screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.
A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.
Detailed description
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM < 2 mm.
Methods:
38 patients presenting one single implant each with a screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.
A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keratinized Mucosa ≥ 2 mm | Experimental | Procedure: Supportive periodontal therapySupportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions |
| Keratinized Mucosa < 2 mm | Experimental | Procedure: Supportive periodontal therapySupportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients> 18 years;
- smokers <10 cigarettes / day;
- partially edentulous patients. The spaces must be associated with at least one adjacent mesial and one distal tooth;
- presence of bleeding and / or suppuration on probing, erythema and inflammation;
- absence of radiographic bone loss around implant distance (<2mm from expected radiographic marginal bone level);
Key exclusion criteria (7 listed)
- totally edentulous patients;
- uncontrolled systemic diseases;
- diseases of the mucosa (erosive lichen planus, etc.);
- taking medications that may interfere with periodontal health or healing; (corticosteroids, calcium channel antagonists, antiepileptic drugs, immunosuppressants, etc.)
- pregnant or lactating patients;
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 |
|---|---|---|
| Supportive periodontal therapyA complete professional prophylaxis session will be performed, which includes ultrasound debridement, scaling with curettes and dental polishing with a rubber cup. On the other hand, in implants affected by mucositis, supra and sub-gingival debridement will be performed using a combination of ultrasound with a titanium tip and titanium curettes. All patients will receive personalized hygiene instructions. Patients will be instructed to brush their implants twice daily using the modified Bass technique with a medium-hard manual toothbrush and low-abrasive toothpaste. In addition, they will be taught to use specific interproximal brushes. If access with an interdental brush is not possible, flossing will be indicated. Oral hygiene instructions will be reviewed at each visit. | Procedure or surgery | Keratinized Mucosa < 2 mm, Keratinized Mucosa ≥ 2 mm |
Primary outcome
Bleeding on probing
Time frame: 24 weeks
The main objective of the study is to evaluate the association between MQ and recurrence of mucositis, comparing the bleeding index on probing (BoP) in implants that have mucositis, in a control group characterized by 2 mm or more of MQ and a test group characterized by less than 2 mm of MQ over a 24-week period after peri-implant maintenance therapy.
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 9 Aug 2022.
- Derived from this study: PubMed 38426741Blasi G, Chierico F, Amerio E, Alvarez G, Isabal S, Arredondo A, Blanc V, Nart J, Monje A. Influence of keratinized mucosa width on the resolution of peri-implant mucositis: A prospective cohort study. Clin Implant Dent Relat Res. 2024 Jun;26(3):581-591. doi: 10.1111/cid.13317. Epub 2024 Mar 1.
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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.
Jose Nart, DDS PhD study chair
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive periodontal therapy in people with Peri-Implantitis and Peri-implant Mucositis, run by Universitat Internacional de Catalunya 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 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 9 Aug 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 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. 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?
Bleeding on probing (time frame: 24 weeks). 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 NCT04874467, 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 9 Aug 2022.