Regenerative Surgical Treatment of Peri-implant Defects

University of Santiago de Compostela

Status: Unknown

Conditions: Implant Site Pocket Infection

Treatments: Procedure: regenerative treatment periimplantitis

Study type: Interventional

Funder types: Other

Identifiers

NCT04440241

REGT_CT_19

Details and patient eligibility

About

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.

Full description

The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:

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

The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.

Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Non-removable prostheses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Test group

Experimental group

Description:

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

Treatment:

Procedure: regenerative treatment periimplantitis

Control group

Experimental group

Description:

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

Treatment:

Procedure: regenerative treatment periimplantitis