Evaluation of peri implant soft and hard tissues between internal hexagonal and internal conical type of implant abutment connection- A randomised controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Levels of Crestal bone loss
Study Overview
Brief Summary
Dental implant treatment is widely used to reconstruct functional and aesthetic problems in partially and fully edentulous patients. However, implant-prosthetic treatment is not free of possible complications and limitations.Stability of peri-implant tissues appears to be one critical component for long term implant success and is influenced by many factors including surgical trauma, biological width establishment, lack of passive fit of superstructures, implant-abutment connection, etc.
The type of implant-abutment connection(IAC) has been considered to be one of the major factors affecting the peri-implant hard and soft tissues. IAC is the point of contact between the surgical and prosthetic phase and is required to provide adequate joint strength, rotational stability, prosthetic indexing and resistance to microbial penetration.
IAC are of two types- External and Internal connection. Internal connection are further diversified into numerous design in an attempt to achieve better microbial seal and joint stability which include internal hex and internal conical.
Few studies have been conducted on comparing these two internal connections and the obtained results were variable.
The purpose of the study is to comparatively evaluate the effect of two implant abutment connection- internal hexagonal and internal conical on peri-implant soft and hard tissue after occlusal loading.
This evaluation will be done based on following parameters-
1. Hard tissue parameter- Crestal bone loss
2. Soft tissue parameters- Probing depth and bleeding on probing
3. IL-1 beta levels in peri-implant sulcus fluid.
These parameters will be recorded during delivery of prosthesis (before occlusal loading-baseline) and 3, 6 and 12 months after occlusal loading. The recorded data will be tabulated and analysed and results will be drawn.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient in the age group of 18years or above who will be able to understand the procedure and be able to provide informed consent to participate in it.
- •Partially edentulous in posterior region(molar and premolar).
- •Patients with simplified oral hygiene index score less than 3
- •Patients having sufficient bone to allow optimal implant placement without the need of bone augmentation or recontouring and having sufficient distaance from vital tissues(2mm).
- •Presence of keratinized tissue more than 2mm
- •Stable posterior occlusion
- •Presence of adjacent teeth (1.5mm).
Exclusion Criteria
- •Patient with a history of systemic disease that precludes standard implant therapy.
- •Patients having parafunctional habits
- •Patient with a current daily smoking habit or chewing tobacco and with a history of drug abuse or alcoholism within past years
- •Pregnant or lactating mother.
Outcomes
Primary Outcomes
Levels of Crestal bone loss
Time Frame: parameters will be recorded during the time of delivery of prosthesis | 3 months after occlusal loading | 6 months after occlusal loading | 12 months after occlusal loading
Levels of IL-1beta
Time Frame: parameters will be recorded during the time of delivery of prosthesis | 3 months after occlusal loading | 6 months after occlusal loading | 12 months after occlusal loading
Change in bleeding on probing index
Time Frame: parameters will be recorded during the time of delivery of prosthesis | 3 months after occlusal loading | 6 months after occlusal loading | 12 months after occlusal loading
Change in probing depth
Time Frame: parameters will be recorded during the time of delivery of prosthesis | 3 months after occlusal loading | 6 months after occlusal loading | 12 months after occlusal loading
Secondary Outcomes
No secondary outcomes reported