"Surgical Vs. Non-surgical Peri-implant Therapy"

NCT05168891 | Completed

• 1 other identifier: PER-ECL-2019-05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized clinical trial is to evaluate the effectiveness, in terms of clinical and radiographic changes, of non-surgical peri-implant therapy (mechanical/chemical) versus regenerative surgical therapy (xenograft and collagen membrane), after a follow-up period of 12 months.

Conditions

Peri-Implantitis; Implant Complication; Bone Loss

Keywords

peri-implantitis; non-surgical therapy; reconstructive therapy; bone graft

Outcome Measures

Primary Outcomes (1)

• Defect fil (mm)

  peri-implant defect fill (≥1.0 mm and \< 1 mm) from radiographic baseline

  12 months after therapy

Secondary Outcomes (9)

• Implant Pocket probing depth (PPD) (mm)

  12 months after therapy

• modified Plaque Index (mPI)

  12 months after therapy

• modified Bleeding Index (mBI)

  12 months after therapy

• Bleeding on probing (BOP) (%)

  12 months after therapy

• Suppuration on probing (SUP) (%)

  12 months after therapy

Study Arms (2)

Test group (TG)

EXPERIMENTAL

Patients will receive professional supragingival teeth/implant prophylaxis, oral hygiene instructions, and implant-supported prosthesis corrections if needed. After 1 week, peri-implant non-surgical therapy combined with antibiotic regimen consisting on metronidazole 500 mg every 8 hours for 7 days will be performed. Finally, the patients will be enrolled in a peri-implant maintenance therapy (PIMT) program every 3 months.

Procedure: Non-surgical therapy of peri-implantitis

Control group (CG)

EXPERIMENTAL

Patients will receive professional supragingival teeth/implant prophylaxis, oral hygiene instructions, and implant-supported prosthesis corrections if needed. After 1 week, peri-implant non-surgical therapy combined with antibiotic regimen consisting on metronidazole 500 mg every 8 hours for 7 days will be performed. After one month, the regenerative surgical therapy will be performed as it follows: the intrabony component of the defect will be filled with a xenograft and covered with a collagen membrane allowing a non-submerged healing. Finally, the patients will be enrolled in a PIMT program every 3 months.

Procedure: Surgical therapy; Procedure: Non-surgical therapy of peri-implantitis

Interventions

Surgical therapy PROCEDURE

Peri-implantitis surgical therapy by means of open flap debridement, detoxification/decontamination of the implant surface and xenograft regeneration.

Also known as: Reconstructive therapy for the management of peri-implantitis

Control group (CG)

Non-surgical therapy of peri-implantitis PROCEDURE

Peri-implant non-surgical therapy combined with antibiotic regimen consisting on metronidazole 500 mg every 8 hours for 7 days will be performed

Also known as: Non surgical debridement

Control group (CG); Test group (TG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years old.
• Presence of ≥ 1 endosseous implants with clinical and radiographic signs of peri- implantitis \[i.e., peri-implant bone level ≥ 3mm apical to the most coronal portion of the intraosseous part of the implant, PPD ≥ 6 mm, and presence of bleeding and/or suppuration on gentle probing (BOP/SOP).
• Implant function time ≥ 1 year.
• Vertical peri-implant bone defect (defects of 2-3 walls and a defect depth ≥ 3 mm).
• Presence of at least 2 mm of keratinized mucosa.
• Absence of active periodontal disease.
• Good level of oral hygiene (Plaque Index \< 25%) (O'Leary et al. 1972)
• Screw-retained single-unit crowns and partial dental prosthesis that allowed correct access for brushing; and, if not,
• Prostheses that could be modified.
• Absence of occlusal overload.

You may not qualify if:

• Clinical implant mobility.
• Radiographic peri-implant bone loss \> 50%.
• Pregnancy or lactating females.
• Any medical condition which contraindicated surgical peri-implant therapy.
• Previous non-surgical treatment (i.e., subgingival debridement) of the affected implants at least 12 months before.
• Previous surgical treatment of the affected implants.
• Systemic diseases, medications, or conditions that may compromise wound healing influencing the outcome of the therapy.
• Known allergy or intolerance to metronidazole or ibuprofeno.
• Use of systemic antibiotics during the previous 3 months.
• Use of systemic antibiotics for endocarditis prophylaxis.
• Smoking more than 10 cigarettes/day.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Institut Straumann AG: collaborator

Study Sites (1)

Universitat Internacional de Catalunya (UIC)

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jose Nart, PhD

  Universitat Internacional de Catalunya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the nature of the study design, neither the patient nor the operator will be blinded. On the other hand, two blinded investigators will collect and record all the clinical and radiological measurements, respectively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentistry, Master in Periodontics and Implants

Model Details: This is a prospective, single-blinded, randomized, controlled clinical trial with 1-year follow-up.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 23, 2021
• Study Start: February 20, 2022
• Primary Completion: February 20, 2022
• Study Completion: February 28, 2023
• Last Updated: March 30, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)