Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05615051
• Other study ID #: 31102022
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)

• Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes

• Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.

The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion:

• Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.

• All patients in age of 18 to 80

• non-smokers

• no presence of systemic disease or medication known to alter bone metabolism

• partial or complete edentulous patients that have no active periodontal disease.

Exclusion criteria:

• pregnancy or lactation

• history of or current smokers

• uncontrolled medical conditions,

• lacking keratinized mucosa (=2mm) on the lingual or buccal implant sites,

• advanced(A) peri-implantitis (>50% of the implant length).

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Device:
• Surface decontamination procedure aiming at reconstructive therapy
Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis

Locations

Country	Name	City	State
Spain	Clinica CICOM	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of the disease	No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss	12 months
Secondary	Radiographic bone gain	Bone gain when compared to baseline bone level	12 months