Clinical trial NCT03819075: Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis
Official title: An Evaluation Of Effectiveness Of A Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Keywords: laser
Er:YAG
Nd:YAG
periimplantitis
randomized controlled trial
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups; laser and control
Primary purpose: TREATMENT

Brief summary: A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.

Detailed description: The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.

Eligibility criteria: Inclusion Criteria:

* at least one implant with peri-implantitis
* no serious mobility of the implants
* written informed consent of the voluntary participant in the study
* availability of participant for control visits for a follow-up of at least 12 months without interruptions

Exclusion Criteria:

* serious systematic disease
* pregnancy
* current use of photosensitive drugs, bisphosphonate medication or antibiotics
* patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits

Primary outcomes:
measure: Proportion of participants with treatment success
timeFrame: 6 months
Secondary outcomes:
measure: Plaque index
timeFrame: 1 month
measure: Plaque index
timeFrame: 3 months
measure: Plaque index
timeFrame: 6 months
measure: Plaque index
timeFrame: 12 months
measure: Bleeding on probing
timeFrame: 1 month
measure: Bleeding on probing
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 6 months
measure: Bleeding on probing
timeFrame: 12 months
measure: Probing depth
timeFrame: 1 month
measure: Probing depth
timeFrame: 3 months
measure: Probing depth
timeFrame: 6 months
measure: Probing depth
timeFrame: 12 months
measure: Mucosal recession
timeFrame: 1 month
measure: Mucosal recession
timeFrame: 3 months
measure: Mucosal recession
timeFrame: 6 months
measure: Mucosal recession
timeFrame: 12 months
measure: Clinical attachment level gain
timeFrame: 1 month
measure: Clinical attachment level gain
timeFrame: 3 months
measure: Clinical attachment level gain
timeFrame: 6 months
measure: Clinical attachment level gain
timeFrame: 12 months
measure: Quality of life questionnaire
timeFrame: 0 months
measure: Quality of life questionnaire
timeFrame: 1 month
measure: Quality of life questionnaire
timeFrame: 3 months
measure: Quality of life questionnaire
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto Universitário de Ciências da Saude, CESPU
Study officials:
affiliation: Instituto Universitário de Ciências da Saude, CESPU
name: Luis Monteiro, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References: