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

Not Applicable
Conditions
Health Condition 1: K068- Other specified disorders of gingiva and edentulous alveolar ridge
Registration Number
CTRI/2023/07/055458
Lead Sponsor
Geetha Arul Mohan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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
NameTimeMethod
Evaluation of secondary stability using Resonance frequency analyser in healthy and diabetic individualsTimepoint: subjects will be followed at baseline, 2 and 4 months
Secondary Outcome Measures
NameTimeMethod
Evaluation of Primary stability and Crestal bone levels in healthy and diabetic individualsTimepoint: subjects will be followed at baseline, 2 and 4 months
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