Evaluation of secondary stability in Healthy and Diabeticindividuals using conventional SLA implants andTrabecular Tantalum implants. A Randomized controlledtrial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Evaluation of secondary stability using Resonance frequency analyser in healthy and diabetic individuals
Study Overview
Brief Summary
Implants are a preferred choice in the treatment of edentulism. There are various factors including implant surface characteristics and wettability which decide successful osseointegration. Common problems faced by patients during conventional implant treatment includes long waiting time for successful osseointegration usually 3-4 months, which is further delayed in diabetics( upto 6 months). Even though immediate loading is practiced, uncertainties due to lack of biological osseointegration prevails, which posses unique challenges for the clinicians especially in medically compromised individuals with diabetes mellitus. Hence there is always a quest for new implant designs and superior surface characteristics for shortened osseointegration time and to reduce the overall treatment duration with special emphasis for diabetic patients. Resonance frequency analysis (RFA) is a predictable non invasive tool, for evaluating the primary and secondary stability in numerous study.
a. Traditional protocols propose that the implant should receive no loading during the osseointegration period usually 3-4 months in healthy individuals which is further higher in diabetics resulting in longer waiting period for the patients without teeth and compromised overall quality of life.
b. A successful osseointegration is based on many factors that influence the formation and maintenance of bone at the implant surface such as the implant micro and macro surface characteristics, bone quality, primary stability, absence of micro motion, absence of infection during healing, aseptic surgical protocol and patient’s systemic conditions.
c. Presently various implants are available with superior surface modifications like SLA active and trabecular tantalum implants. These implant surfaces have shown faster osseointegration.
d. The trabecular implants, With a high coefficient of friction (0.98), it provides excellent initial scratch fit. Unlike coatings and other surfaces, it has up to80% porosity, enhancing the potential for bone ingrowth and soft tissue vascularization. With its nano-textured struct architecture, Trabecular implants are similar to cancellous bone in structure, function, and physiology. The Structure supports bone integration, bone remodeling and vascularization. These properties enhances the rate of osseointegration, thus reducing the overall treatment duration.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for diabetic individuals: 1.diabetic patients with HbA1C: 6.1-8 [Group III and group IV] 2.Patients who are between 18-60 years of age 3.All sites had to be healed sites, that is at least 6 months of post extraction healing was required 4.Mandibular edentulous sites Inclusion criteria for healthy individuals: 1.Non diabetic patients with HbA1C- less than 6.1 [Group I and group II] 2.Patients who are between 18-60 years of age 3.All sites had to be healed sites, that is at least 6 months of post extraction healing was required 4.Mandibular edentulous sites.
Exclusion Criteria
- •Exclusion criteria for diabetic individuals: 1.HbA1C levels exceeding 8 are excluded 2.History of oral /intravenous bisphosphonate use for >3 years 3.Smokers 4.Pregnancy or lactation 5.Known allergy to any material or medication used in the study 6.Any Previous History of head and neck radiation therapy 7.Chemotherapy in the last 12 months 8.Severe psychologic problems 9.Patient not willing to sign the consent approved by the Human Studies Committee 10.Debilitating systemic diseases or conditions that have a clinically significant effect on wound healing Exclusion criteria for healthy individuals: 1.HbA1C levels exceeding 6.1 are excluded[Group I and group II] 2.History of oral /intravenous bisphosphonate use for >3 years 3.Smokers 4.Pregnancy or lactation 5.Known allergy to any material or medication used in the study 6.Any Previous History of head and neck radiation therapy 7.Chemotherapy in the last 12 months 8.Severe psychologic problems 9.Patient not willing to sign the consent approved by the Human Studies Committee 10.Debilitating systemic diseases or conditions that have a clinically significant effect on wound.
Outcomes
Primary Outcomes
Evaluation of secondary stability using Resonance frequency analyser in healthy and diabetic individuals
Time Frame: subjects will be followed at baseline, 2 and 4 months
Secondary Outcomes
- Evaluation of Primary stability and Crestal bone levels in healthy and diabetic individuals(subjects will be followed at baseline, 2 and 4 months)