Evaluation of stability of two types of dental implants placed for the management of edentulous space in healthy and diabetic individuals

Not yet recruiting

Conditions: Other specified disorders of gingiva and edentulous alveolar ridge,

Registration Number: CTRI/2023/07/055458

Lead Sponsor: Geetha Arul Mohan

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 patientâ€™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 to**80% 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of secondary stability using Resonance frequency analyser in healthy and diabetic individuals	subjects will be followed at baseline, 2 and 4 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of Primary stability and Crestal bone levels in healthy and diabetic individuals	subjects will be followed at baseline, 2 and 4 months

Trial Locations

Locations (1): SRM Dental college
🇮🇳
Chennai, TAMIL NADU, India
SRM Dental college
🇮🇳Chennai, TAMIL NADU, India
Geetha Arul Mohan
Principal investigator
9943320006
mail2algeetha@gmail.com