Diode Laser for Treatment of Peri-implantitis

NCT ID: NCT03383120

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2021-04-30

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.

Detailed Description

Peri-implantitis is a major complication for dental implant patients, with its prevalence estimated in the order of 10% of implants and 20% of patients after 5 to 10 years of implant placement. When left untreated, peri-implantitis may cause progressive tissue destruction, esthetic complications and, eventually, implant loss. Despite numerous clinical trials and systematic reviews, studies have failed to identify a standardized protocol for the treatment of such conditions. Still, current literature and expert opinions recommend mechanical debridement of the implant followed by early evaluation and surgical intervention, implant decontamination using a wide variety of mechanical and chemical methods, then adjunctive systematic antibiotics. However, given the aggressive nature of surgical interventions, the inherent difficulty of decontaminating the implants' rough surfaces with conventional methods, in addition to the growing concerns over antibiotic resistance, the search for alternative approaches has become imperative. Since implant decontamination is the key aspect to resolution of peri-implantitis, different mechanical and chemical methods have been tested in that respect. In recent years, lasers have been attracting significant attention in this particular field. Diode lasers, in particular, have been shown to have potent bactericidal and photobiomodulatory effects promoting wound healing and tissue regeneration. Therefore, the aim of this randomized controlled clinical trial is to evaluate the clinical and patient-centered outcomes of non-surgical debridement with adjunctive repeated diode laser application in comparison with conventional surgical treatment with adjunctive systemic antibiotics for treatment of peri-implantitis lesions following an observation period of one year.

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.

40 subjects will be randomly distributed into two parallel groups:

1. Test group (n= 20); receiving non-surgical mechanical debridement and adjunctive diode laser application at days 0, 7 and 14.

2. Control group (n= 20); receiving initial mechanical debridement at day 0, followed by open flap debridement and prescription of post-operative systemic antimicrobials at day 14.

Conditions

Peri-Implantitis; Implant Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser

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).

Group Type: EXPERIMENTAL

Laser treatment

Intervention Type: 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.

Surgery

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.

Group Type: ACTIVE_COMPARATOR

Surgical treatment with adjunctive systemic antibiotics

Intervention Type: 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

Interventions

Laser treatment

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.

Intervention Type: DEVICE

Surgical treatment with adjunctive systemic antibiotics

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

Intervention Type: PROCEDURE

Other Intervention Names

Test; Control

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Geneva, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Dena Hashim

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Geneva

Geneva, Genève 4, Switzerland

Countries

Switzerland

Other Identifiers

2016-02205

Identifier Type: -

Identifier Source: org_study_id