Therapeutic Peri-implant Maintenance With Laser Therapy

Straipsnius versti gali tik registruoti vartotojai

Prisijungti Registracija

Nuoroda įrašoma į mainų sritį

Statusas

Rėmėjai

University of Michigan

Bendradarbiai

Morita J USA

KLINIKINIS TYRIMAS: NCT04251793

BioSeek: nct04251793

Raktažodžiai

Santrauka

The present study represents an extension of the previously concluded randomized clinical trial "Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis" (HUM00124386). The aim of the study is to compare the adjunctive effect of laser over mechanical debridement alone in the maintenance of peri-implant tissues after surgical treatment of peri-implantitis (gum disease around implants).

apibūdinimas

The same 24 subjects, previously treated with surgical regenerative treatment of peri-implantitis following the LARST protocol, will be invited to return for three follow-up visits. During the follow-up visits, clinical measurements, x-rays, and pictures of the inside of their mouth will be taken to evaluate the success of their peri-implantitis treatment. If needed, additional laser treatment of the dental implant may also be provided according to the same randomization of subjects in the original study. No placebo laser application will be provided.

Datos

Paskutinį kartą patikrinta:	12/31/2019
Pirmasis pateikimas:	01/29/2020
Numatytas registravimas pateiktas:	01/29/2020
Pirmas paskelbtas:	02/04/2020
Paskutinis atnaujinimas pateiktas:	01/29/2020
Paskutinis atnaujinimas paskelbtas:	02/04/2020
Faktinė studijų pradžios data:	07/07/2019
Numatoma pirminio užbaigimo data:	12/30/2020
Numatoma studijų užbaigimo data:	12/30/2020

Būklė ar liga

Peri-Implantitis

Intervencija / gydymas

Other: Observation

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
Er:YAG laser-assisted debridement Subjects who were randomly selected to receive debridement and surface detoxification of their implant surface and removal of the inflamed tissue with the aid of the laser treatment two years ago at the Graduate Periodontics Clinic at University of Michigan.
Standard mechanical debridement Subjects who were randomly selected to receive debridement and surface detoxification of their implant surface and removal of the inflamed tissue with dental scalers two years ago at the Graduate Periodontics Clinic at University of Michigan.

Tinkamumo kriterijai

Tinkamos studijoms lytys	All
Mėginių ėmimo metodas	Non-Probability Sample
Priima sveikus savanorius	Ne
Kriterijai	Inclusion Criteria: - Subjects who were previously enrolled subjects in the randomized clinical trial of laser-assisted regenerative surgical therapy Exclusion Criteria: - Unable to reach the subject - The implant is mobile or lost Premature Exclusion Criteria: - The researcher believes that it is not the best interest of the subject to stay in the study - If the subject becomes ineligible to participate based on the exclusion criteria - If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc.) - If the subject does not follow study related instructions - The study is suspended or canceled.

Rezultatas

Pirminės rezultatų priemonės

1. Change in Periodontal Probing Depths (PD) [Baseline and 6 months]

PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks

Antrinės rezultatų priemonės

1. Change in Clinical Attachment Level (CAL) [Baseline and 6 months]

CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 6 months.

2. Change in marginal bone level (MBL) [Baseline and 6 months]

Marginal bone level will be measured compared to baseline. Participants' standardized radiographs will be used to determine bone level changes between baseline and 6 months.