Evaluation of peri implant soft tissue and hard tissue in bone level and tissue level implants: A Randomized Control Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- RajaRajeswari Dental College & Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Implant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick)
Overview
Brief Summary
Background:
Osseo-integration is a prerequisite for long-term implant stability. Proper soft tissue seal to the titanium surfaces at the most coronal aspect of the implant body is required to prevent pathology that may interfere with osseo-integration process.
Conventional or bone level implants involve a two-stage surgery. Here, first the implant is placed at bone level after flap elevation and sutured for osseo-integration. In second stage, after 10-14 weeks, again a flap is raised to place the gingival former for another 3 weeks. Here the implant-abutment junction is in close proximity to the crestal bone.
It has been observed that the implant-abutment junction creates a micro-gap that creates path for the inflammatory infiltrate to cause marginal bone loss (die-back effect) and apical migration of junctional epithelium.
Better understanding of peri implant bone regeneration has led to more refined concepts of implant loading.
Tissue-level implants involve a single stage surgery where the tissue level abutment is placed along with the implant. It is attributed to creating a good mucosal seal of adequate width that mimics the biologic width. They have been attributed to eliminate the implant-abutment junction at the crestal bone level and shifts this junction at the tissue level, thus eliminating the micro-gap between these components. Prosthetic procedures don’t disturb the mucosal seal and protects it from contaminated oral surface.
In tissue level implants healing of bone and gingiva occurs simultaneously. It has been observed that this creates an early mucosal seal and disturb its seal during prosthetic steps.
The purpose of this study is to evaluate peri-implant soft-tissue and hard-tissue health conditions and changes seen in bone level and tissue level implants post prosthetic rehabilitation in these implants1. To assess the peri-implant soft tissue thickness in bone level and tissue level implants both pre-operatively and post-operatively.
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To assess the peri-implant soft changes seen in bone level and tissue level implants.
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To assess any crestal bone changes around the implant in bone level and tissue level implants.
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To evaluate the peri-implant soft-tissue and hard-tissue changes following prosthetic rehabilitation in bone level and tissue level implants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients in the age group of 18 to 60 years
- •Patient Should be partially edentulous in posterior region of maxilla or mandible
- •Patients with good oral hygiene
- •ASA I and ASA II.
Exclusion Criteria
- •ASA III and ASA IV, Pregnant or nursing women, Patients smoking more than 10 cigarettes a day, poor periodontal status, need for regenerative procedure and Intake of drugs that can interfere with bone healing and remodeling.
Outcomes
Primary Outcomes
Implant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick)
Time Frame: Implant Stability at 0, 3 and 6 months: | Modified Sulcus Bleeding Index 0, 3 and 6 months: | Peri-Implant Probing Depth 0, 3 and 6 months: | Marginal Bone Loss 0, 3 and 6 months: | Keratinized tissue height 3 and 6 months and Gingival Biotype
Secondary Outcomes
- mplant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick)(Implant Stability at 0, 3 and 6 months:)
Investigators
Amit Kashyap M R
Rajarajeshwari Dental college and hospital