NCT02406001

Brief Summary

The purpose of this randomized trial was to compare reconstructive surgery of advanced peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap debridement (OFD/Control) in a non-submerged technique over 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

3.6 years

First QC Date

December 9, 2014

Last Update Submit

March 31, 2015

Conditions

Peri-implantitis

Keywords

peri-implantitisosseous defectsimplant surface decontaminationbone graftingsurgical therapyporous titanium granulesreconstruction

Outcome Measures

Primary Outcomes (1)

  • changes in radiographic bone level (mm)

    baseline and 6 month after treatment

Secondary Outcomes (6)

  • % radiographic defect fill

    baseline and 6 month after treatment

  • % radiographic defect resolution

    baseline and 6 month after treatment

  • Pocket Probing Depth (PPD)

    baseline and 6 month after treatment

  • Bleeding on Probing (BoP)

    baseline and 6 month after treatment

  • Suppuration (PUS)

    baseline and 6 month after treatment

  • +1 more secondary outcomes

Study Arms (2)

Tigran PTG

EXPERIMENTAL

Surgical intervention: open flap debridement and implantation of bone grafting material

Device: Tigran PTGProcedure: Surgical intervention

Control

OTHER

Surgical intervention: open flap debridement

Procedure: Surgical intervention

Interventions

Tigran PTGDEVICE

Open Flap Debridement

Tigran PTG
Surgical interventionPROCEDURE

Open Flap Debridement

ControlTigran PTG

Eligibility Criteria

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

You may qualify if:

  • All implants had to be in function for more than 12 months. Only one implant per patient was included in the study.
  • By initial radiographic evaluation:
  • Intraosseous defect ≥ 3 mm defect depth on standard intraoral radiograph.
  • By clinical evaluation:
  • Peri-implant probing depth (PD) ≥ 5 mm
  • Bleeding (BOP) and/or suppuration (PUS)
  • By intra-operative exploration:
  • Intra-osseous defect component ≥ 3 mm at the deepest point
  • to 4 wall intra-osseous
  • Osseous defect with at least 270 degrees (circumferential)
  • Defect angle ≤ 35 degrees (from axis of implant)

You may not qualify if:

  • Subjects with diabetes mellitus (HbA1c ≥6.5)
  • Subjects taking corticosteroids or other anti-inflammatory prescription drugs.
  • Subjects taking medications known to induce gingival hyperplasia
  • Subjects with a history of taking systemic antibiotics in the preceding month.
  • Patients pregnant or nursing
  • Implants placed in grafted bone or previously augmented with bone /bone substitute or other type of regenerative material
  • Implants previously surgically treated for peri-implantitis
  • Failure to obtain soft tissue closure
  • Mobile implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tigran Technologies AB

Malmo, SE 205 12, Sweden

Location

Related Publications (3)

  • Chan HL, Lin GH, Suarez F, MacEachern M, Wang HL. Surgical management of peri-implantitis: a systematic review and meta-analysis of treatment outcomes. J Periodontol. 2014 Aug;85(8):1027-41. doi: 10.1902/jop.2013.130563. Epub 2013 Nov 21.

    PMID: 24261909BACKGROUND

  • Khoshkam V, Chan HL, Lin GH, MacEachern MP, Monje A, Suarez F, Giannobile WV, Wang HL. Reconstructive procedures for treating peri-implantitis: a systematic review. J Dent Res. 2013 Dec;92(12 Suppl):131S-8S. doi: 10.1177/0022034513509279. Epub 2013 Oct 24.

    PMID: 24158331BACKGROUND

  • Jepsen K, Jepsen S, Laine ML, Anssari Moin D, Pilloni A, Zeza B, Sanz M, Ortiz-Vigon A, Roos-Jansaker AM, Renvert S. Reconstruction of Peri-implant Osseous Defects: A Multicenter Randomized Trial. J Dent Res. 2016 Jan;95(1):58-66. doi: 10.1177/0022034515610056. Epub 2015 Oct 8.

    PMID: 26450511DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Stefan Renvert, Prof

    Dep of Health Sciences Univ of Kristianstad Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

April 1, 2015

Study Start

June 1, 2010

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

SE(1)