Diode Laser for Treatment of Peri-implantitis

NCT03383120 | Completed DMC

• 1 other identifier: 2016-02205
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.

Conditions

Peri-Implantitis; Implant Complication

Keywords

Peri-implantitis; Diode laser; Surgical debridement

Outcome Measures

Primary Outcomes (4)

• Resolution of the peri-implantitis

  Defined as A absence of probing depths \> 4 mm, bleeding on probing or suppuration at the end of the observation period

  12 months

• Types and frequencies of adverse events

  Any adverse events related or unrelated to the treatment administered is recorded at the time and appropriate treatment is performed. The frequency, duration and intensity is also recorded.

  12 months

• Patient reported outcomes at 1 week

  A visual analogue scale is used to evaluate post-operative discomfort and patient's perception of the administered treatment 1 week post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating absence of pain and 100 being the worst pain imaginable.

  1 week post-operatively

• Patient reported outcomes at 12 months

  A visual analogue scale is used to evaluate general patient's perception of the administered treatment 12 months post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating lack of discomfort or pain and complete satisfaction and 100 being completely unsatisfied and/or with persisting pain or other symptoms.

  12 months

Secondary Outcomes (4)

• Change in marginal bone levels

  12 months

• Differences between groups regarding changes in mean marginal bone level changes

  12 months

• Number of residual pockets > 4 mm

  12 months

• Changes in probing depth

  12 months

Study Arms (2)

Laser

EXPERIMENTAL

Mechanical debridement of the implant surface using an ultra-sonic device with saline irrigation and plastic curettes, followed by soft tissue curettage using a metallic curette. Adjunctive sub-mucosal diode laser application according to the instructions of the manufacturer (settings: 810 nm, 2.5 W, 50 Hz, 10 ms), 3x for 30 seconds, using a 400-µm thick fiber (Doctor Smile Wiser diode laser, Orcos Medical AG, Küsnacht, Switzerland), will be performed three times at one week intervals (days 0, 7, and 14).

Device: Laser treatment

Surgery

ACTIVE COMPARATOR

Active control includes mechanical debridement of the implant surface using an ultra-sonic device with saline irrigation and plastic curettes, followed by soft tissue curettage using a metallic curette at day 1. An open flap debridement procedure is performed at day 14 using normal saline for implant decontamination. Adjunctive systemic antimicrobials will be prescribed; Amoxi-mepha 500mg 3x/day and Metronidazole 500mg 3x/day, for 1 week. A chlorhexidine 0.2% mouth rinse will also be prescribed 2x/day for one week. Suture removal and prophylaxis are performed 7-10 days post-operatively.

Procedure: Surgical treatment with adjunctive systemic antibiotics

Interventions

Laser treatment DEVICE

Laser treatment of the peri-implantitis lesion includes mechanical debridement of the implant using an ultrasonic device and plastic curettes followed by diode laser sub-mucosal application for 90 seconds. This is repeated two more times at one-week intervals.

Also known as: Test

Laser

Surgical treatment with adjunctive systemic antibiotics PROCEDURE

Mechanical debridement of the implant will be done in a similar manner to the test group (without laser application) followed by open flap debridement 2 weeks after, and post-operative prescription of Amoxicillin and Metronidazole systemic antibiotics 3 times per day for a period of 1 week

Also known as: Control

Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• At least one solid screw-type titanium implant diagnosed with peri-implantitis; which is defined as at least one site with probing depth ≥5mm, bleeding on probing and/or suppuration, and radiographic evidence of crater-form bone loss ≥2 threads after insertion of the final prosthetic supra-structure.
• Sound prosthetic supra-structure.

You may not qualify if:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Amoxicillin and/or Metronidazole,
• Systemic diseases that could compromise wound healing (i.e. uncontrolled diabetes mellitus, cancer, HIV or bone metabolic disorders), radiation or immunosuppressive therapy,
• Women who are pregnant or breast feeding,
• Known or suspected non-compliance, drug or alcohol abuse,
• Heavy smokers consuming \>10 cigarettes/day,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participants not willing to attend regular dental maintenance visits and follow-up evaluations,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Active periodontal disease.

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

University of Geneva

Geneva, Genève 4, 1211, Switzerland

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Laser Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The treatment group will be concealed at all time points from both clinical examiners (N.C., A.Z.) and the biostatistician (D.C.). Only the operator (D.H.) will be aware of the type of treatment to be performed based on the computer-generated allocation table. The un-blinded operator will perform the first follow-up visit one week post-operatively to ensure blinding of the examiners.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, single-centre, superiority, randomized, controlled clinical trial

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 26, 2017
• Study Start: October 10, 2017
• Primary Completion: October 30, 2020
• Study Completion: April 30, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

CH (1)