NCT02575274

Brief Summary

The purpose of this experimental study in humans is to evaluate and compare, the regenerative therapy for the treatment of peri-implantitis using different bone substitutes and absorbable membranes with surgical therapy without the use of materials for regeneration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

January 29, 2015

Last Update Submit

October 11, 2015

Conditions

Peri-implantitis

Keywords

Peri-implantitisPeri-implant diseaseDental implantsGuided bone regeneration

Outcome Measures

Primary Outcomes (1)

  • Changes in peri-implant probing depth

    Peri-implant probing depth measured in millimeters with peri-implant probe

    one year and half. Pre-operative, after surgery: 6, 12 and 18 months

Secondary Outcomes (1)

  • Changes in radiographic marginal bone level on standardized intraoral radiographs

    One year and half. Pre operative and after surgery: immediatelly, 6, 12 and 18 months

Other Outcomes (1)

  • Presence of bleeding on probing

    One year and half. Before treatment and after 6, 12, 18 months post surgery

Study Arms (2)

JHS COL-HAP91 + JHS HAP-91

EXPERIMENTAL

Surgical flaps debridement with plastic curette Implacare Hu-Friedy, cleaning the surface with chlorhexidine gel 2% 3 minutes and irrigation with saline solution 0.9 %. Bone defects will be treated with JHS COL-HAP91 (porous hydroxyapatite + collagen) + JHS HAP-91 (porous hydroxyapatite). Amoxicillin 500 mg 3 times/day 7 days, Tylenol 750 mg 3 times/day, and Nimesulide 100 mg 2 times/day will be prescribed.

Procedure: Surgical flaps

surgical and mechanical debridement

OTHER

Surgical flaps: All groups will receive the same surgical treatment for implant surface decontamination. Surgical intervention will be performed with full thickness mucoperiosteal flaps. Debridement with plastic curette Implacare Hu-Friedy, cleaning the surface with chlorhexidine gel 2% 3 minutes and irrigation with saline solution 0.9 %. Amoxicillin 500 mg 3 times/day 7 days, Tylenol 750 mg 3 times/day and Nimesulide 100 mg 2 times/day will be prescribed.

Procedure: Surgical flaps

Interventions

Surgical flapsPROCEDURE

Surgical intervention will be performed with full thickness mucoperiostal flaps to obtain access in the bone defects. All groups will receive the same treatment for implant surface decontamination: debridement with plastic curette Implacare Hu-Friedy®, cleaning the surface with chlorhexidine gel 2% during 3 minutes and abundant irrigation with saline solution 0.9%.

JHS COL-HAP91 + JHS HAP-91surgical and mechanical debridement

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • It will include individuals diagnosed with early to moderate peri-implantitis (probing depth between 5 and 10 mm) rehabilitated with implant supporting fixed prosthesis for at least 6 months. Due to the great variation in implants' length the probing depth can shows great variability. In this way it is complicated to establish a cutoff point to define the severity of the disease. So in order to minimize this limitation, the peri-implant bone defect should be angular or circular involving at least 3 threads and should not exceed 50% of the total length of the implant.

You may not qualify if:

  • Smokers
  • Individuals with blood glucose more than 120 mg/dl or Insulin dependent diabetes
  • Individuals who have undergone treatment of peri-implant disease over the last 6 months
  • Individuals who used antibiotic therapy, for any reason, in the last 3 months
  • Individuals who have any systemic condition that prevents surgical treatment
  • Refusal to sign the informed consent
  • A history of local radiotherapy to the head and neck region
  • Pregnancy and lactation
  • Active, uncontrolled periodontal pathology of the remaining dentition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30110031, Brazil

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created StructuresEquipment and Supplies

Study Officials

  • Sergio D Ferreira, MsC

    Doctoral student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 29, 2015

First Posted

October 14, 2015

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

BR(1)