Air-polishing in the Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Air-polishing in the Treatment of Peri-implantitis - a Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04847648
• Other study ID #: 2021-00169
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: October 1, 2027

Study information

• Verified date: February 2023
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to evaluate the potential benefit of the adjunctive use of an air-polishing device in the treatment of peri-implantitis as compared to mechanical infection control alone. Following establishment of adequate patient-performed infection control, 80 patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be randomized to one of two groups. Non-surgical and, if required, surgical therapy will be carried out by experienced operators in three clinical centers and the mechanical instrumentation (control group) will be supplemented by the use of air-polishing with erythritol powder (AirFlow Master, EMS, Nyon, Switzerland) in the test group. The primary outcome assessed is "pocket closure" (ie probing pocket depth ≤5 mm & absence of profuse bleeding on probing) after non-surgical (6 months) and surgical therapy (18 months). Secondary outcomes include changes of clinical signs of soft tissue inflammation, adverse events and patient-reported outcome measures. Outcomes of non-surgical therapy will be evaluated at 3 and 6 months. Sites with remaining pathology at 6 months will be subjected to surgical therapy.

Description:

The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers. 80 systemically healthy patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be enrolled. Upon enrolment, all patients will receive instructions in oral hygiene measures until adequate plaque control has been established (Plaque Index ≤20%). If required, supraconstructions will be adjusted to facilitate adequate oral hygiene measures. Thereafter, study participants will be randomized into two groups, stratified for smoking (yes/no) and number of implants in need of treatment (single/multiple). The control group will be subjected to professionally administered mechanical infection control including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the target sites. In the test group the aforementioned treatment will be supplemented by the use of an air-polishing device (AirFlow Master, EMS, Nyon, Switzerland) with a specially designed nozzle for sub-mucosal application (PerioFlow Handpiece, EMS, Nyon, Switzerland). Following local anesthesia, the instrument will be used sub-mucosally at all aspects (ie mesial, distal, buccal, lingual) of the affected implant(s) at a power setting reduced to 60% and with a erythritol powder (14 mikrometer, AirFlow Plus Powder, EMS, Nyon, Switzerland). The handpiece will be guided in a circular motion in a corono-apical direction not in contact with the implant surface. Instrumentation time will be limited to 5 seconds at each aspect. Implant-supported supraconstructions will not be removed for the non-surgical treatment. Patients are recalled two weeks later for assessment of patient-experienced outcomes, professional supramucosal cleaning and reinforcement of oral hygiene. Peri-implant soft tissues will be evaluated at three months. Implant sites with remaining signs of pathology (PPD ≥6 mm and presence of BOP at ≥3 aspects per implant will be subjected to re-treatment according to the initial allocation. The clinical evaluation will be repeated at 6 months. In case of residual signs of pathology, affected sites will be subjected to surgical therapy of peri-implantitis within the subsequent 4 weeks. Full thickness flaps will be elevated and inflamed tissues will be removed. Mineralized deposits on the implant surfaces will be removed with titanium-coated curettes. Surface decontamination will be performed using a rotating titanium brush under irrigation with saline. No bone recontouring of bony walls is intended. Flaps will be sutured to the level of the bone and sutures will be removed after 2 weeks. Implant-supported supraconstructions will be removed for the surgical intervention, if possible. Maintenance therapy will be provided at 9 and 12 months and based on individual needs during the subsequent follow-up. A renewed evaluation will be performed at 12 and 18 months. Long-term assessments will be carried out annually from years 3 to 5. Should any implant site present with signs of disease progression (increase of PPD >2 mm and additional bone loss >1 mm compared to baseline) at any of the follow-up examinations, the implant will be exited from the study and appropriate additional therapy will be provided.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 1, 2027
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Probing pocket depth of =6 mm
• Bleeding and/or suppuration on probing at =3 aspects per implant
• Documented radiographic bone loss of =2 mm.

Exclusion Criteria:

• Implants with bone loss =80% of implant length will not be considered.
• No medical conditions prohibiting non-surgical/surgical treatment of peri-implantitis
• Implant(s) in function =1 year

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Procedure:
• Air-polishing
Air-polishing with erythritol powder during non-surgical therapy (at baseline, 5 seconds per surface, and, if necessary, at 3 months).
• Mechanical decontamination
Mechanical instrumentation of implant surfaces during non-surgical therapy (at baseline and, if necesarry at 3 months) including the use of hand instruments and polishing cups aiming at the removal of all soft and hard deposits from the target implant.

Locations

Country	Name	City	State
Sweden	Department of Periodontology, Institute of Odontology	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants/implants displaying pocket closure	Pocket closure: Probing pocket depth of =5 mm and absence of bleeding on probing at =3 aspects per implant and absence of suppuration on probing	3 months
Primary	Proportion of participants/implants displaying pocket closure	Pocket closure: Probing pocket depth of =5 mm and absence of bleeding on probing at =3 aspects per implant and absence of suppuration on probing	6 months
Primary	Proportion of participants/implants displaying pocket closure	Pocket closure: Probing pocket depth of =5 mm and absence of bleeding on probing at =3 aspects per implant and absence of suppuration on probing	18 months
Primary	Patient satisfaction assessed by visual analogue scale	Patient satisfaction as assessed on a 100 mm VAS	3 months
Primary	Patient satisfaction assessed by visual analogue scale	Patient satisfaction as assessed on a 100 mm VAS	6 months
Primary	Patient satisfaction assessed by visual analogue scale	Patient satisfaction as assessed on a 100 mm VAS	18 months
Secondary	Changes in probing pocket depth	Reductions in PPD relative to baseline	3 months
Secondary	Changes in probing pocket depth	Reductions in PPD relative to baseline	6 months
Secondary	Changes in probing pocket depth	Reductions in PPD relative to baseline	18 months
Secondary	Changes in probing pocket depth	Reductions in PPD relative to baseline	3 years
Secondary	Changes in probing pocket depth	Reductions in PPD relative to baseline	4 years
Secondary	Changes in probing pocket depth	Reductions in PPD relative to baseline	5 years
Secondary	Changes in bleeding on probing	Reductions in BOP relative to baseline	3 months
Secondary	Changes in bleeding on probing	Reductions in BOP relative to baseline	6 months
Secondary	Changes in bleeding on probing	Reductions in BOP relative to baseline	18 months
Secondary	Changes in bleeding on probing	Reductions in BOP relative to baseline	3 years
Secondary	Changes in bleeding on probing	Reductions in BOP relative to baseline	4 years
Secondary	Changes in bleeding on probing	Reductions in BOP relative to baseline	5 years
Secondary	Changes in marginal soft soft tissue levels	Changes in marginal soft soft tissue levels relative to baseline	3 months
Secondary	Changes in marginal soft soft tissue levels	Changes in marginal soft soft tissue levels relative to baseline	6 months
Secondary	Changes in marginal soft soft tissue levels	Changes in marginal soft soft tissue levels relative to baseline	18 months
Secondary	Changes in marginal soft soft tissue levels	Changes in marginal soft soft tissue levels relative to baseline	3 years
Secondary	Changes in marginal soft soft tissue levels	Changes in marginal soft soft tissue levels relative to baseline	4 years
Secondary	Changes in marginal soft soft tissue levels	Changes in marginal soft soft tissue levels relative to baseline	5 years
Secondary	Changes in radiographic bone levels	Changes in radiographic bone levels relative to baseline	6 months
Secondary	Changes in radiographic bone levels	Changes in radiographic bone levels relative to baseline	18 months
Secondary	Changes in radiographic bone levels	Changes in radiographic bone levels relative to baseline	3 years
Secondary	Changes in radiographic bone levels	Changes in radiographic bone levels relative to baseline	5 years
Secondary	Rate of adverse events	Emphysema	3 months
Secondary	Rate of adverse events	Emphysema	6 months
Secondary	Rate of adverse events	Emphysema	18 months
Secondary	Patient discomfort as expressed on a visual analogue scale	Patient discomfort 2 weeks after non-surgical treatment as expressed on a 100 mm VAS	3.5 months
Secondary	Patient discomfort as expressed on a visual analogue scale	Patient discomfort 2 weeks after surgical treatment as expressed on a 100 mm VAS	6.5 months
Secondary	Esthetic appreciation as expressed on a visual analogue scale	Esthetic appreciation as expressed on a 100 mm VAS	3 months
Secondary	Esthetic appreciation as expressed on a visual analogue scale	Esthetic appreciation as expressed on a 100 mm VAS	6 months
Secondary	Esthetic appreciation as expressed on a visual analogue scale	Esthetic appreciation as expressed on a 100 mm VAS	18 months