Treatment of Inflammation Around Implants With a Laser or an Ultrasonic Device

NCT05772299 | Completed

• 1 other identifier: P-I mucositis
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the clinical trial is to compare laser therapy with ultrasonic therapy in patients with inflammation in the tissue surrounding single implants (peri-implant mucositis). The outcomes are bleeding on probing (BOP), pocket depth, suppuration, recession of the peri-implant mucosal margin, the treatment time and changes in bone levels before and after treatment in the test, and control group respectively. The quality of life will be measured from a standardized protocol. The hypothesis is that treatment with laser therapy in patients with peri-implant mucositis will show less inflammation with less bleeding and a better pocket closure compared to the treatment with the ultrasound.

Conditions

Peri-implant Mucositis

Keywords

Clinical study; Bleeding on probing; Pus; Er:Yag laser; Ultrasonic device

Outcome Measures

Primary Outcomes (12)

• Bleeding on probing (BOP)

  millimeter

  Baseline

• Bleeding on probing (BOP)

  millimeter

  1 month

• Bleeding on probing (BOP)

  millimeter

  3 months

• Bleeding on probing (BOP)

  millimeter

  6 months

• Probing pocket depth (PPD)

  millimeter

  Baseline

• Probing pocket depth (PPD)

  millimeter

  1 month

• Probing pocket depth (PPD)

  millimeter

  3 months

• Probing pocket depth (PPD)

  millimeter

  6 months

• Pus

  Presence or abscence

  Baseline

• Pus

  Presence or abscence

  1 month

• Pus

  Presence or abscence

  3 months

• Pus

  Presence or abscence

  6 months

Secondary Outcomes (13)

• Recession of the peri-implant mucosal margin

  Baseline

• Recession of the peri-implant mucosal margin

  6 months

• Bone level (peri-apical radiographs)

  Baseline

• Bone level (peri-apical radiographs)

  6 months

• Implant loss

  Baseline

Study Arms (2)

Er:Yag laser treatment

EXPERIMENTAL

The experimental (test) group will receive the following treatment: The submucosal debridement will be performed with an Er:Yag laser (AdvErL EVO, Morita Corporation, Japan). The P-400 tip is placed into the peri-implant mucositis pockets mesially, lingually, distally and buccally while rinsing water. Careful attempts are to cover the full circumference of the implant.

Radiation: Er:Yag laser

Ultrasonic device treatment

ACTIVE COMPARATOR

The active comparator (control) group will receive the following treatment: The submucosal debridement will be performed by a piezoelectric ultrasonic device with a PEEK coated tip (EMS, Switzerland). The tip is placed into the peri-implant mucositis pockets mesially, lingually, distally and buccally while rinsing water. Careful attempts are to cover the full circumference of the implant.

Device: EMS ultrasound

Interventions

Er:Yag laser RADIATION

Submucosal debridement is performed with Er:Yag laser using a P-400 tip under rinsing water.

Er:Yag laser treatment

EMS ultrasound DEVICE

Submucosal debridement is performed with piezoelectric ultrasound (EMS) with a PEEK (plastic coated) tip under rinsing water.

Ultrasonic device treatment

Eligibility Criteria

• Age: 23 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 1 peri-implant site with probing depth ≥ 4 mm combined with bleeding and or pus on probing
• bone loss ≤ 2 mm measured from the implant shoulder (as a consequence of remodelling during the healing process)

You may not qualify if:

• Subjects with uncontrolled diabetes HbA1c \>6.5
• Subjects requiring prophylactic antibiotics
• Subjects taking prednisolone
• Subjects taking medications known to have effects on gingival overgrowth

Sponsors & Collaborators

• Kristianstad University: lead

Study Sites (1)

University of Kristianstad

Kristianstad, 29893, Sweden

Location

Related Publications (8)

• Aoki A, Sasaki KM, Watanabe H, Ishikawa I. Lasers in nonsurgical periodontal therapy. Periodontol 2000. 2004;36:59-97. doi: 10.1111/j.1600-0757.2004.03679.x. No abstract available.

  PMID: 15330944 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 BACKGROUND

• Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.

  PMID: 25495683 BACKGROUND

• Lin GH, Suarez Lopez Del Amo F, Wang HL. Laser therapy for treatment of peri-implant mucositis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):766-782. doi: 10.1902/jop.2017.160483.

  PMID: 30133748 BACKGROUND

• Renvert S, Lessem J, Dahlen G, Lindahl C, Svensson M. Topical minocycline microspheres versus topical chlorhexidine gel as an adjunct to mechanical debridement of incipient peri-implant infections: a randomized clinical trial. J Clin Periodontol. 2006 May;33(5):362-9. doi: 10.1111/j.1600-051X.2006.00919.x.

  PMID: 16634959 BACKGROUND

• Renvert S, Persson GR, Pirih FQ, Camargo PM. Peri-implant health, peri-implant mucositis, and peri-implantitis: Case definitions and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S304-S312. doi: 10.1002/JPER.17-0588.

  PMID: 29926953 BACKGROUND

• Takasaki AA, Aoki A, Mizutani K, Kikuchi S, Oda S, Ishikawa I. Er:YAG laser therapy for peri-implant infection: a histological study. Lasers Med Sci. 2007 Sep;22(3):143-57. doi: 10.1007/s10103-006-0430-x. Epub 2007 Jan 12.

  PMID: 17219255 BACKGROUND

• Bengtsson VW, Aoki A, Mizutani K, Lindahl C, Renvert S. Treatment of peri-implant mucositis using an Er:YAG laser or an ultrasonic device: a randomized, controlled clinical trial. Int J Implant Dent. 2025 Jan 24;11(1):6. doi: 10.1186/s40729-025-00591-0.

  PMID: 39853624 DERIVED

MeSH Terms

Conditions

Suppuration

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Stefan Renvert, Prof

  Kristianstad University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor, in this case the dental hygienist performing the registrations/measurement, is blinded during the whole study The principal investigator, in this case the periodontologist performing all the treatments, and is therefore not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Test group: will be treated using the Er:Yag laser device (AdvErL EVO, Morita Corporation, Japan). The tip is placed in the pocket mesially, lingually, distally and buccally. Control group: will be treated using an ultrasonic device with PEEK coated tips (EMS, Switzerland). The tip is placed in the pocket mesially, lingually, distally and buccally.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: August 31, 2021
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)