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Peri-ImplantitisNCT05574218

Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis

A study testing Glycine air powder and Rubber cup polishing in people with Peri-Implantitis, run by Universidad Complutense de Madrid.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT). Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. Read more about this study

Who is it for?
Any age
Conditions the study is for
Peri-Implantitis
What is being tested?
Glycine air powder and Rubber cup polishing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Jan 2013to Aug 2021
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

  • Presence of at least one implant with peri-implantitis, defined as: radiographic evidence of bone loss >2 mm, inflammation of the peri-implant mucosa as defined by positive BoP and/or suppuration, and at least one site with PD ≥ 5 mm.
  • Based on the radiographic examination, the affected implant should not have a vertical peri-implant defect. Positive selection was based on the presence of pe-ri-implant lesions wider than 4 mm, with an angle greater than 35 º.
  • In patients with a history of periodontitis, periodontal therapy should have been provided at least 6 months prior to the initiation of the study.

Who cannot join

  • Presence of relevant medical conditions and/or systemic medications that would contraindicate the surgical procedure or modify the tissue response after therapy.
  • Patients requiring antibiotic prophylaxis.
  • Heavy smokers (> 10 cigarettes/day).
  • Pregnant or lactating women

About this study

Official title: Effect of a Maintenance Protocol Based on the Surgical Treatment of Peri-implantitis and Implant Surface Decontamination With Glycine Powder Air-polishing

This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT). Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Read the detailed description

Study design:

This study was designed as a 12-month, two arms, RCT to evaluate the efficacy of a SPIC protocol. Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Interventions:

At the 6-month evaluation after the surgery, the baseline data for the present study were obtained and patients were randomised using a computerized block randomization protocol to one of the following SPIC protocols. In the test group, implant surfaces were treated with glycine powder air-polishing after ultrasonic instrumentation; the specific nozzle was activated subgingivally and circumferentially around the implant for 1 minute. In the control group, implants were cleaned with a rubber cup and polishing paste after ultrasonic instrumentation. This SPIC visits were carried out at 6 (baseline visit), 9, 12, 15 and 18 months after surgery.

Being tested
Glycine air powder, Rubber cup polishing
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glycine air powderProcedure or surgery

    Every 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant. Then, the implants were treated with glycine powder air-polishing.

  • Rubber cup polishingProcedure or surgery

    Every 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant. Then, the implants were treated with rubber cup and a polishing paste.

Study groups in NCT05574218
Study groupRoleWhat they receive
Glycine - TestExperimentalPolishing treatment with glycine powder air-polishing after ultrasonic plaque debridement.
Receives: Procedure: Glycine air powder
Rubber cup - ControlActive comparatorPolishing treatment with a rubber cup and polishing paste after ultrasonic debridement
Receives: Procedure: Rubber cup polishing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probing Pocket Depth

    Changes in Probing Pocket Depth measured in milimeters with a manual periodontal probe

    Measured: Baseline, 6 and 18 months after the surgical procedure

Secondary outcomes (10)
  1. Distance of Gingival Recession

    Recession distance of the mucosal margin relative to the restoration margin (REC) at the implant (6 sites/implant) measured in milimeters with a manual periodontal probe

    Measured: Baseline, 6 and 18 months after the surgical procedure

  2. Bleeding on Probing index

    Rate of Presence / absence Bleeding on Probing at the implant (6 sites/implant)

    Measured: Baseline, 6 and 18 months after the surgical procedure

  3. Plaque Index

    Rate of Presence / absence of Plaque at the implant (6 sites/implant)

    Measured: Baseline, 6 and 18 months after the surgical procedure

  4. Suppuration Index

    Rate of Presence / absence of suppuration at the implant (6 sites/implant)

    Measured: Baseline, 6 and 18 months after the surgical procedure

  5. Radiographic bone loss distance measured from the prosthetic connection platform to the bottom of the intraosseous defect

    Intraoral standardised radiographs of the site of interest measured in digital intraoral radiographs using an image-processing software

    Measured: Baseline, 6 and 18 months after the surgical procedure

  6. Concentration of the selected cytokines measured in pg/ml (IL1B; Il-6; IL-8; Tumoral Necrosis Factor Alpha)

    Samples taken from the gingival crevicular fluid (GCF) were taken from each included implant from the deepest PD site with positive BoP, at baseline and at the final evaluation, always prior to microbiological sampling. Samples were taken using the filter paper technique. After isolation of the area with cotton rolls and gentle cleaning with air and a gauze to remove supragingival biofilm deposits and potential saliva contamination, a paper strip of standard length and height was inserted into the peri-implant pocket, until mild resistance was felt and left in place for 30 seconds. The soaked volume of GCF was measured using the Periotron 8000® device. Subsequently, the paper strips were inserted in micro-centrifuge plastic tubes and immediately stored at -80°C until further processing. Analyses were carried out using a Luminex System (Luminex® 200, Luminex Corporation, Austin, TX, USA) to determine volume of the following biomarkers: IL-1β, IL-6, IL-8 and TNF-α.

    Measured: Baseline, 6 and 18 months after the surgical procedure

  7. Presence of putative periodontal pathogens

    Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.

    Measured: Baseline, 6 and 18 months after the surgical procedure

  8. Frequency of detection of putative periodontal pathogens

    Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.

    Measured: Baseline, 6 and 18 months after the surgical procedure

  9. Proportions of putative periodontal pathogens

    Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.

    Measured: Baseline, 6 and 18 months after the surgical procedure

  10. Counts of putative periodontal pathogens

    Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.

    Measured: Baseline, 6 and 18 months after the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study startJan 2013
  3. Primary completionAug 2021
  4. Study completionAug 2021

Resources

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
Model description
Randomized Clinical Trial
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574218
Sponsor's protocol ID
EMS/MTO
Status last verified
Sep 2022
First submitted
26 Sep 2022
Last updated
10 Oct 2022
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Glycine air powder and Rubber cup polishing in people with Peri-Implantitis, run by Universidad Complutense de Madrid.

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 3 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 10 Oct 2022. 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. 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?

Probing Pocket Depth (time frame: Baseline, 6 and 18 months after the surgical procedure). 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 10 Oct 2022.

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