NCT03241953

Brief Summary

In this randomized, controlled study, 18 patients with peri-implantitis were included. A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing using abrasive powders or conventional plastic scaler with klorhegsidin combination.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

2.6 years

First QC Date

August 3, 2017

Last Update Submit

August 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment results

    It was found in the study that the combined air-flow debridement and the mechanical debridement performed by using ultrasonic polyetheretherketone-coated tips developed for implant surface debridement in peri-implantitis therapy were better at decreasing the level of periodontal pocket depth than plastic curettes

    one year

Study Arms (2)

debridement made by ultrasonic tips

EXPERIMENTAL

mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement

Procedure: Periodontal surgery

implants were debrided with standard plastic curettes

ACTIVE COMPARATOR

dental implants were debrided with standard plastic curettes, debridement made by combined klorhegsidin rinse

Procedure: Periodontal surgery

Interventions

A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing

debridement made by ultrasonic tipsimplants were debrided with standard plastic curettes

Eligibility Criteria

Age30 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- The patients, who were systemically and periodontally healthy and free of parafunctional habits like bruxism, and didn't have any kind of periodontal therapy within the previous year and had implants for at least 5 years, were included in the study.

You may not qualify if:

  • The patients with chronic bronchitis or asthma and major systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) and those who had taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days were excluded in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Peri-ImplantitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof.Dr.

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

April 23, 2014

Primary Completion

November 20, 2016

Study Completion

December 22, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share