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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

Evaluation of secondary stability in Healthy and Diabetic individuals using conventional SLA implants and Trabecular Tantalum implants. A Randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055458
Enrollment
40
Registered
2023-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K068- Other specified disorders of gingiva and edentulous alveolar ridge

Interventions

Intervention1: intervention agent- Group II: Trabecular implants will be placed in healthy individuals for management of edentulous sites in mandible Intervention2: intervention agent- Group IV: Trab

Sponsors

Geetha Arul Mohan
Lead Sponsor
SRM Dental College
Collaborator

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

MeasureTime frame
Evaluation of secondary stability using Resonance frequency analyser in healthy and diabetic individualsTimepoint: subjects will be followed at baseline, 2 and 4 months

Secondary

MeasureTime frame
Evaluation of Primary stability and Crestal bone levels in healthy and diabetic individualsTimepoint: subjects will be followed at baseline, 2 and 4 months

Countries

India

Contacts

Public ContactGeetha Arul Mohan

SRM university

hari_feb14@hotmail.com9840482400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026