Peri-implant MucositisPiM_IncNCT05356806
Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis
An observational study of Peri-implant Mucositis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Supportive periodontal and periimplant care
- Type of treatment
- Pill or oral medicine
- How many people
- 277 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with treated periodontitis who have had dental implants placed at the Periodontics Specialist Clinic of the UCM School of Dentistry, and are going to be rehabilitated in the same center
Who may be able to join
- Over 18 years of age, able to comply with the protocol and comply with the established visits.
- Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).
- Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis [individual, partial or complete], hybrid or overdenture).
- Physical or mental conditions that make it possible to perform appropiate oral hygiene
Who cannot join
- Patients with untreated periodontitis.
- Totally edentulous patients.
- Patients with peri-implant diseases.
- Pregnant or in lactating-period patients.
- Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).
- Patients who have taken antibiotics in the last month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
María Rioboo, Dr contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, University Complutense of Madrid (UCM)
Madrid, 28040
Elena Figuero, Prof., 0034913942186, elfiguer@ucm.es
Maria Rioboo, Dr., mrioboo@ucm.es
About this study
Official title: Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.
the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.
Read the detailed description
Introduction: Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.
Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.
- Conditions
- Peri-implant Mucositis
- Being tested
- Supportive periodontal and periimplant care
- Keywords
- peri-implant mucositis, incidence, biofilm, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive periodontal and periimplant careOther
Periodontal and peri-implant maintenance therapy will be carried out at baseline, 3 and 6-month visit. This session will include the removal of biofilm and calculus on teeth and implants (except those that have just been restored) with an ultrasonic device using a plastic tip ( for implants. and a conventional metal tip ( for teeth. At the end, polishing will be done with a rubber cup
Subsequently, patients will be explained that they must continue with their usual oral hygiene technique on their teeth, using the same type of brush (which can be electric or manual), interproximal devices, toothpaste or mouthwash used to date. Finally, they will receive specific instructions for the supragingival biofilm control in the area of the new restoration and will be given interdental brushes that suit to the space
| Study group | Role | What they receive |
|---|---|---|
| One | Patients with treated periodontitis who have had dental implants placed at the Periodontics Specialist Clinic of the UCM School of Dentistry, and are going to be rehabilitated. Receives: Other: Supportive periodontal and periimplant care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peri-implant mucositis
The risk of developing PM (patient with at least one implant who has bleeding on probing, with or without suppuration and without progressive radiographic bone loss) during a follow-up period of 12 months.
Measured: 12 months
Secondary outcomes (50)
Affiliation data
Age, Sex
Measured: Baseline
previous medical history
systemic diseases, medication, allergies
Measured: Baseline
smoking habit
ex-smoker/smoker/non-smoker
Measured: Baseline
Other general data
sports habit, educational level, alcohol and coffee consumption, type of diet.
Measured: Baseline
Previous dental history
history of periodontitis, periodontal treatment received (date of maintenance therapy, basic or surgical treatment), as well as the presence of previous peri-implant diseases will be recorded. Toothbrushing device used by the patient (manual or electric toothbrush) will also be recorded.
Measured: Baseline
Characteristics of the teeth that have been replaced by implants
Options:single tooth in the anterior region, single tooth in the posterior region, tooth with distal extension, interdental space, edentulous upper jaw, edentulous lower jaw
Measured: Baseline
Surgical procedure
bone regeneration procedures (prior, simultaneous, immediate implant), alveolar preservation, use of platelet derivatives, use of bone graft (autologous, xenogenic, mixed), use of membranes, sinus lift or soft tissue augmentation.
Measured: Baseline
Implant characteristics
location (maxillary, mandibular, both), implant system (brand, implant position relative to bone and soft tissue, platform change, configuration, implant material), surface topography (roughness index), diameter and length (measured in millimeters),
Measured: Baseline
Characteristics of the restorations
existence or not of an intermediate abutment and its characteristics, retention of the crown (cemented, screw-retained, cement-retained or other), type of prosthetic restoration (fixed prosthesis [individual, partial or complete], hybrid or overdenture ), crown material (metal-porcelain, ceramic, zirconium or resin), crown design method (CAD-CAM/casting) and impression-taking method (intraoral scanner, registration with silicone measurements) and if there are clinical signs of bruxism
Measured: Baseline
Mucosal thickness (GM)
it will be measured with a K45 file (Stainless Steal K-File, Dentsply Maillefer, Ballaigues, Switzerland) and PCP15 periodontal probe calibrated in millimeters (HuFriedy® , Chicago, IL, USA), 1 mm from mucosal margin and at the buccal and lingual center of each implant.
Measured: Baseline
Mucosal height
(once the abutment/healing screw has been removed, before placing the restoration): distance from the margin of the peri-implant mucosa to the implant head. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA), in 6 locations for each implant.
Measured: Baseline
Modified plaque index (mPI)
Score 0: no plaque detected; score 1: plaque is only recognized by passing a probe over the smooth marginal surface of the implant; score 2: the plaque is visible; score 3: abundance of soft plaque.
Measured: Baseline
Modified plaque index (mPI)
Score 0: no plaque detected; score 1: plaque is only recognized by passing a probe over the smooth marginal surface of the implant; score 2: the plaque is visible; score 3: abundance of soft plaque.
Measured: 6 months
Modified plaque index (mPI)
Score 0: no plaque detected; score 1: plaque is only recognized by passing a probe over the smooth marginal surface of the implant; score 2: the plaque is visible; score 3: abundance of soft plaque.
Measured: 12 months
Modified sulcus bleeding Index (mBI)
Score 0: no bleeding when passing a periodontal probe along the mucosal margin adjacent to the implant; score 1: visible isolated bleeding point; score 2: the bleed forms a confluent red line in the margin; score 3: profuse bleeding.
Measured: Baseline
Modified sulcus bleeding Index (mBI)
Score 0: no bleeding when passing a periodontal probe along the mucosal margin adjacent to the implant; score 1: visible isolated bleeding point; score 2: the bleed forms a confluent red line in the margin; score 3: profuse bleeding.
Measured: 6 months
Modified sulcus bleeding Index (mBI)
Score 0: no bleeding when passing a periodontal probe along the mucosal margin adjacent to the implant; score 1: visible isolated bleeding point; score 2: the bleed forms a confluent red line in the margin; score 3: profuse bleeding.
Measured: 12 months
Bleeding on probing (BOP)
assessed dichotomously within 15 seconds of probing. Bleeding must be clear (a spot bleed will not be considered positive).
Measured: Baseline
Bleeding on probing (BOP)
assessed dichotomously within 15 seconds of probing. Bleeding must be clear (a spot bleed will not be considered positive).
Measured: 6 months
Bleeding on probing (BOP)
assessed dichotomously within 15 seconds of probing. Bleeding must be clear (a spot bleed will not be considered positive).
Measured: 12 months
Suppuration on probing (Sup):
evaluated dichotomously after probing.
Measured: Baseline
Suppuration on probing (Sup):
evaluated dichotomously after probing.
Measured: 6 months
Suppuration on probing (Sup):
evaluated dichotomously after probing.
Measured: 12 months
Probing depth (PS)
defined as the distance in mm between the depth of the pocket and the margin of the peri-implant tissue.
Measured: Baseline
Probing depth (PS)
defined as the distance in mm between the depth of the pocket and the margin of the peri-implant tissue.
Measured: 6 months
Probing depth (PS)
defined as the distance in mm between the depth of the pocket and the margin of the peri-implant tissue.
Measured: 12 months
Crown length (CL):
defined as the distance, in mm, between the incisal/occlusal part of the crown and the margin of the peri-implant tissue.
Measured: Baseline
Crown length (CL):
defined as the distance, in mm, between the incisal/occlusal part of the crown and the margin of the peri-implant tissue.
Measured: 6 months
Crown length (CL):
defined as the distance, in mm, between the incisal/occlusal part of the crown and the margin of the peri-implant tissue.
Measured: 12 months
Width of the mucosa:
distance from the mucosal margin to the mucogingival line at the buccal and lingual center. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA).
Measured: Baseline
Width of the mucosa:
distance from the mucosal margin to the mucogingival line at the buccal and lingual center. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA).
Measured: 6 months
Width of the mucosa:
distance from the mucosal margin to the mucogingival line at the buccal and lingual center. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA).
Measured: 12 months
full-mouth periodontal clinical parameters
will be recorded at 6 locations per tooth and implant with a PCP15 periodontal probe (HuFriedy®, Chicago, IL, USA). These include PS, recession (REC), BOP, clinical attachment level (CAL), plaque index (PI), Sup.
Measured: Baseline
full-mouth periodontal clinical parameters
will be recorded at 6 locations per tooth and implant with a PCP15 periodontal probe (HuFriedy®, Chicago, IL, USA). These include PS, recession (REC), BOP, clinical attachment level (CAL), plaque index (PI), Sup.
Measured: 6 months
full-mouth periodontal clinical parameters
will be recorded at 6 locations per tooth and implant with a PCP15 periodontal probe (HuFriedy®, Chicago, IL, USA). These include PS, recession (REC), BOP, clinical attachment level (CAL), plaque index (PI), Sup.
Measured: 12 months
Radiographic bone level
defined as the distance between the implant shoulder and the first visible contact between the implant surface and the most apical position of the bone in mesial and distal. For transmucosal implants, the length of the intermediate abutment will not be taken into account. Implant distances (length and diameter) will be used for fit and distortion. In visit 1, a perpendicular line to the major axis of the implant will be drawn, coinciding with the position of the bone level, this reference will be the guide to assess possible discrepancies in the following visits.
Measured: Baseline
Radiographic bone level
defined as the distance between the implant shoulder and the first visible contact between the implant surface and the most apical position of the bone in mesial and distal. For transmucosal implants, the length of the intermediate abutment will not be taken into account. Implant distances (length and diameter) will be used for fit and distortion. In visit 1, a perpendicular line to the major axis of the implant will be drawn, coinciding with the position of the bone level, this reference will be the guide to assess possible discrepancies in the following visits.
Measured: 6 months
Radiographic bone level
defined as the distance between the implant shoulder and the first visible contact between the implant surface and the most apical position of the bone in mesial and distal. For transmucosal implants, the length of the intermediate abutment will not be taken into account. Implant distances (length and diameter) will be used for fit and distortion. In visit 1, a perpendicular line to the major axis of the implant will be drawn, coinciding with the position of the bone level, this reference will be the guide to assess possible discrepancies in the following visits.
Measured: 12 months
Implant-Abutment Gap
Presence of space between implant and abutment and excess cement (surrounding excess cement will be explored).
Measured: Baseline
Implant-Abutment Gap
Presence of space between implant and abutment and excess cement (surrounding excess cement will be explored).
Measured: 6 months
Implant-Abutment Gap
Presence of space between implant and abutment and excess cement (surrounding excess cement will be explored).
Measured: 12 months
Emergence angle and profile (concave/straight or convex) of restorations
The angle of the restoration will be measured mesial and distal according to the criteria established by Yotnuengnit et al. (Yotnuengnit et al., 2008). The emergence of the angle will be calculated between the length of the major axis of the implant and the tangent line to the restoration, then a tangential line is made from the restoration to the platform, the intersection angle is measured as an emergency angle. These measurements will be repeated twice for each mesial and distal surface. Each emergence profile will be categorized as concave, straight, or convex. For implants placed at bone level, the transmucosal abutment will be considered as a part of the restoration. According to this criterion, restorations with at least a 30º angle will be considered "over-contoured" (Kohal et al., 2003). Concave, convex and straight profile categories will awarded according to this emergency.
Measured: Baseline
Emergence angle and profile (concave/straight or convex) of restorations
The angle of the restoration will be measured mesial and distal according to the criteria established by Yotnuengnit et al. (Yotnuengnit et al., 2008). The emergence of the angle will be calculated between the length of the major axis of the implant and the tangent line to the restoration, then a tangential line is made from the restoration to the platform, the intersection angle is measured as an emergency angle. These measurements will be repeated twice for each mesial and distal surface. Each emergence profile will be categorized as concave, straight, or convex. For implants placed at bone level, the transmucosal abutment will be considered as a part of the restoration. According to this criterion, restorations with at least a 30º angle will be considered "over-contoured" (Kohal et al., 2003). Concave, convex and straight profile categories will awarded according to this emergency.
Measured: 6 months
Emergence angle and profile (concave/straight or convex) of restorations
The angle of the restoration will be measured mesial and distal according to the criteria established by Yotnuengnit et al. (Yotnuengnit et al., 2008). The emergence of the angle will be calculated between the length of the major axis of the implant and the tangent line to the restoration, then a tangential line is made from the restoration to the platform, the intersection angle is measured as an emergency angle. These measurements will be repeated twice for each mesial and distal surface. Each emergence profile will be categorized as concave, straight, or convex. For implants placed at bone level, the transmucosal abutment will be considered as a part of the restoration. According to this criterion, restorations with at least a 30º angle will be considered "over-contoured" (Kohal et al., 2003). Concave, convex and straight profile categories will awarded according to this emergency.
Measured: 12 months
Patient reported outcomes
It will be recorded if the patient reports the appearance of pain in peri-implant tissues (no pain/slight pain/moderate pain/severe pain), need of analgesia (yes/no), inflammation (no inflammation/inflammation not visually perceived/evident inflammation) , bleeding (no bleeding/incipient bleeding when brushing/profuse bleeding when brushing), discomfort during brushing (no pain/slight pain/moderate pain/severe pain), collaboration (number of tooth brushings per day), oral hygiene habits (use of interproximal devices in the implants under study).
In addition, type of toothbrush (manual/electric/sonic) and its frequency, use of dental floss (yes/no), use of interproximal brushes (yes/no) and use of mouthrinse (yes/no; frequency, type of mouthwash).
Measured: Baseline
Patient reported outcomes
It will be recorded if the patient reports the appearance of pain in peri-implant tissues (no pain/slight pain/moderate pain/severe pain), need of analgesia (yes/no), inflammation (no inflammation/inflammation not visually perceived/evident inflammation) , bleeding (no bleeding/incipient bleeding when brushing/profuse bleeding when brushing), discomfort during brushing (no pain/slight pain/moderate pain/severe pain), collaboration (number of tooth brushings per day), oral hygiene habits (use of interproximal devices in the implants under study).
In addition, type of toothbrush (manual/electric/sonic) and its frequency, use of dental floss (yes/no), use of interproximal brushes (yes/no) and use of mouthrinse (yes/no; frequency, type of mouthwash).
Measured: 6 months
Patient reported outcomes
It will be recorded if the patient reports the appearance of pain in peri-implant tissues (no pain/slight pain/moderate pain/severe pain), need of analgesia (yes/no), inflammation (no inflammation/inflammation not visually perceived/evident inflammation) , bleeding (no bleeding/incipient bleeding when brushing/profuse bleeding when brushing), discomfort during brushing (no pain/slight pain/moderate pain/severe pain), collaboration (number of tooth brushings per day), oral hygiene habits (use of interproximal devices in the implants under study).
In addition, type of toothbrush (manual/electric/sonic) and its frequency, use of dental floss (yes/no), use of interproximal brushes (yes/no) and use of mouthrinse (yes/no; frequency, type of mouthwash).
Measured: 12 months
Microbiological samples
2 most accessible and/or inflamed locations will be selected. After careful removal of supramucosal biofilm deposits, if any, the areas of interest will be isolated using cotton rolls and air drying. Two sterile paper points (#30, Maillefer, Ballaigues, Switzerland) will be consecutively inserted into the peri-implant sulcus for 30 seconds. Paper points taken from each implant will be placed in a sterile and empty vial and will be sent within a maximum period of 24 hours to the research laboratory of the UCM School of Dentistry for subsequent freezing and processing (Pulcini et al., 2019 ). Analysis of the microbiome using massive sequencing techniques
Measured: Baseline
Microbiological samples
2 most accessible and/or inflamed locations will be selected. After careful removal of supramucosal biofilm deposits, if any, the areas of interest will be isolated using cotton rolls and air drying. Two sterile paper points (#30, Maillefer, Ballaigues, Switzerland) will be consecutively inserted into the peri-implant sulcus for 30 seconds. Paper points taken from each implant will be placed in a sterile and empty vial and will be sent within a maximum period of 24 hours to the research laboratory of the UCM School of Dentistry for subsequent freezing and processing (Pulcini et al., 2019 ). Analysis of the microbiome using massive sequencing techniques
Measured: 6 months
Microbiological samples
2 most accessible and/or inflamed locations will be selected. After careful removal of supramucosal biofilm deposits, if any, the areas of interest will be isolated using cotton rolls and air drying. Two sterile paper points (#30, Maillefer, Ballaigues, Switzerland) will be consecutively inserted into the peri-implant sulcus for 30 seconds. Paper points taken from each implant will be placed in a sterile and empty vial and will be sent within a maximum period of 24 hours to the research laboratory of the UCM School of Dentistry for subsequent freezing and processing (Pulcini et al., 2019 ). Analysis of the microbiome using massive sequencing techniques
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 posted2 May 2022
- Study start10 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Periodoncia (SEPA), Dentaid SL
- Responsible party
- Sponsor
- Investigators
- Elena Figuero, Prof., Principal investigator, Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356806
- Sponsor's protocol ID
- 52-240521
- Acronym
- PiM_Inc
- Status last verified
- Dec 2024
- First submitted
- 26 Apr 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.
- ClinicalTrials.gov ID
- NCT05356806
- Acronym / sponsor ID
- PiM_Inc / 52-240521
- Conditions
- Peri-implant Mucositis
- Keywords
- peri-implant mucositis, incidence, biofilm, periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 277 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Sociedad Española de Periodoncia (SEPA), Dentaid SL
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 May 2022 (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 objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.
Detailed description
Introduction: Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.
Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One | – | Other: Supportive periodontal and periimplant carePatients with treated periodontitis who have had dental implants placed at the Periodontics Specialist Clinic of the UCM School of Dentistry, and are going to be rehabilitated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treated periodontitis who have had dental implants placed at the Periodontics Specialist Clinic of the UCM School of Dentistry, and are going to be rehabilitated in the same center
Key inclusion criteria (4 listed)
- Over 18 years of age, able to comply with the protocol and comply with the established visits.
- Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).
- Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis [individual, partial or complete], hybrid or overdenture).
- Physical or mental conditions that make it possible to perform appropiate oral hygiene
Key exclusion criteria (6 listed)
- Patients with untreated periodontitis.
- Totally edentulous patients.
- Patients with peri-implant diseases.
- Pregnant or in lactating-period patients.
- Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).
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 and periimplant carePeriodontal and peri-implant maintenance therapy will be carried out at baseline, 3 and 6-month visit. This session will include the removal of biofilm and calculus on teeth and implants (except those that have just been restored) with an ultrasonic device using a plastic tip ( for implants. and a conventional metal tip ( for teeth. At the end, polishing will be done with a rubber cup Subsequently, patients will be explained that they must continue with their usual oral hygiene technique on their teeth, using the same type of brush (which can be electric or manual), interproximal devices, toothpaste or mouthwash used to date. Finally, they will receive specific instructions for the supragingival biofilm control in the area of the new restoration and will be given interdental brushes that suit to the space | Other | One |
Primary outcome
Incidence of peri-implant mucositis
Time frame: 12 months
The risk of developing PM (patient with at least one implant who has bleeding on probing, with or without suppuration and without progressive radiographic bone loss) during a follow-up period of 12 months.
50 secondary outcomes
Affiliation data
Time frame: Baseline
previous medical history
Time frame: Baseline
smoking habit
Time frame: Baseline
Other general data
Time frame: Baseline
Previous dental history
Time frame: Baseline
Characteristics of the teeth that have been replaced by implants
Time frame: Baseline
Surgical procedure
Time frame: Baseline
Implant characteristics
Time frame: Baseline
Characteristics of the restorations
Time frame: Baseline
Mucosal thickness (GM)
Time frame: Baseline
Mucosal height
Time frame: Baseline
Modified plaque index (mPI)
Time frame: Baseline
Modified plaque index (mPI)
Time frame: 6 months
Modified plaque index (mPI)
Time frame: 12 months
Modified sulcus bleeding Index (mBI)
Time frame: Baseline
Modified sulcus bleeding Index (mBI)
Time frame: 6 months
Modified sulcus bleeding Index (mBI)
Time frame: 12 months
Bleeding on probing (BOP)
Time frame: Baseline
Bleeding on probing (BOP)
Time frame: 6 months
Bleeding on probing (BOP)
Time frame: 12 months
Suppuration on probing (Sup):
Time frame: Baseline
Suppuration on probing (Sup):
Time frame: 6 months
Suppuration on probing (Sup):
Time frame: 12 months
Probing depth (PS)
Time frame: Baseline
Probing depth (PS)
Time frame: 6 months
Probing depth (PS)
Time frame: 12 months
Crown length (CL):
Time frame: Baseline
Crown length (CL):
Time frame: 6 months
Crown length (CL):
Time frame: 12 months
Width of the mucosa:
Time frame: Baseline
Width of the mucosa:
Time frame: 6 months
Width of the mucosa:
Time frame: 12 months
full-mouth periodontal clinical parameters
Time frame: Baseline
full-mouth periodontal clinical parameters
Time frame: 6 months
full-mouth periodontal clinical parameters
Time frame: 12 months
Radiographic bone level
Time frame: Baseline
Radiographic bone level
Time frame: 6 months
Radiographic bone level
Time frame: 12 months
Implant-Abutment Gap
Time frame: Baseline
Implant-Abutment Gap
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- 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.
María Rioboo, Dr contact
Elena Figuero, Prof. principal investigator
Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena F Figuero, Prof. (0034913942186, elfiguer@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of peri-implant mucositis (time frame: 12 months). 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 12 Dec 2024.