Regenerative Surgical Treatment of Peri-implant Defects

NCT04440241 | Unknown DMC

• 1 other identifier: REGT_CT_19
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high. Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

Conditions

Implant Site Pocket Infection

Outcome Measures

Primary Outcomes (1)

• Changes marginal bone level

  measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.

  baseline, 6 and 12 months

Secondary Outcomes (8)

• Changes Probing pocket depth

  baseline, 6 and 12 months

• Changes Clinical attachment level

  baseline, 6 and 12 months

• Change Reccesion

  baseline, 6 and 12 months

• Change Keratinized mucosa

  baseline, 6 and 12 months

• Change blending on probing

  baseline, 6 and 12 months

Study Arms (2)

Test group

EXPERIMENTAL

submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

Procedure: regenerative treatment periimplantitis

Control group

EXPERIMENTAL

non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

Procedure: regenerative treatment periimplantitis

Interventions

regenerative treatment periimplantitis PROCEDURE

Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect. The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.

Control group; Test group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Systemically healthy patients.
• Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component.
• Absence of mobility of the implants.
• Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded).
• Patient's smoking ≤ 10 cigarettes/day.

You may not qualify if:

• Non-removable prostheses

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Osteology Foundation: collaborator

Study Sites (1)

Master Periodoncia. Facultad odontología

Santiago de Compostela, A Coruña, 15782, Spain

RECRUITING

Related Publications (3)

• Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. doi: 10.1111/j.1600-0501.2006.01320.x.

  PMID: 17348880 RESULT

• Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24.

  PMID: 20374416 RESULT

• Roccuzzo M, Bonino F, Bonino L, Dalmasso P. Surgical therapy of peri-implantitis lesions by means of a bovine-derived xenograft: comparative results of a prospective study on two different implant surfaces. J Clin Periodontol. 2011 Aug;38(8):738-45. doi: 10.1111/j.1600-051X.2011.01742.x. Epub 2011 Jun 2.

  PMID: 21635278 RESULT

Study Officials

• Santiago Mareque

  University of Santiago de Compostela

  STUDY DIRECTOR

Central Study Contacts

Santiago Mareque

CONTACT

616 975 256‬; smareque@gmail.com

Juan Blanco

CONTACT

616 975 256‬; smareque@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator - Juan Blanco Carrión

Model Details: Test group: submerged healing Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)