Therapeutic Peri-implant Maintenance With Laser Therapy

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

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Hali

Wadhamini

University of Michigan

Washirika

Morita J USA

JARIBIO LA KLINIKI: NCT04251793

BioSeek: nct04251793

Maneno muhimu

Kikemikali

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).

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	12/31/2019
Iliyowasilishwa Kwanza:	01/29/2020
Uandikishaji uliokadiriwa Uliwasilishwa:	01/29/2020
Iliyotumwa Kwanza:	02/04/2020
Sasisho la Mwisho Liliwasilishwa:	01/29/2020
Sasisho la Mwisho Lilichapishwa:	02/04/2020
Tarehe halisi ya kuanza kwa masomo:	07/07/2019
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	12/30/2020
Tarehe ya Kukamilisha Utafiti:	12/30/2020

Hali au ugonjwa

Peri-Implantitis

Uingiliaji / matibabu

Other: Observation

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
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.

Vigezo vya Kustahiki

Jinsia Inastahiki Kujifunza	All
Njia ya sampuli	Non-Probability Sample
Hupokea Wajitolea wa Afya	Hapana
Vigezo	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.

Matokeo

Hatua za Matokeo ya Msingi

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

Hatua za Matokeo ya Sekondari

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.