Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects.

Conditions

• Peri Implantitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Staged peri-implant debridement and regeneration — PROCEDURE
  Peri-implant debridement will be carried our in visit one and will be followed by a second surgery for regeneration
• Simultaneous peri-implant debridement and regeneration — PROCEDURE
  The peri-implant defect will be debrided and regenerated at the same visit.

Study Details

The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical reconstruction of peri-implantitis intra-bony defects in terms of the clinical, radiographical, histological, volumetric, microbiological, and patient-reported outcomes. The investigators hypothesize that in certain clinical situations, treatment of peri-implantitis intra-bony defects with the use of a compound bone grafting material (mixture of allogenic bone substitutes) and a non-resorbable barrier membrane and following a delayed approach (test group) with initial phase of defect decontamination and initial healing phase would yield superior outcomes to that of the conventional approach (control group) of defect decontamination and regeneration at the same clinical visit while also significantly enhancing patient-reported outcomes: H0: There is no difference between the two mentioned approaches in terms of the treatment outcomes. H1: There is a significant difference, favoring the delayed approach compared to the immediate reconstruction.

Key Dates

Start date

Jan 12, 2026

Status verified

Dec 2025

Primary completion

Feb 28, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control Group
  The subjects will receive treatment consisting of surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR).
• Experimental: Test Group
  The subjects will receive a two-stage treatment consisting of the surgical removal of peri-implant granulation tissue and pocket epithelium. After 4-6 weeks, they will undergo surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR).

Primary Outcome Measure

Radiographic change [ Time Frame: 12 months ]

Central Contacts

• Purnima Kumar, DDS, PhD
  17347632105
  [email protected]

Locations (1)

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