Clinical trial NCT04189718: Comparative Evaluation of Osseodensification Versus Conventional Implant Site
Official title: A Clinical and Radiological Comparison of Osseodensification Versus Conventional Implant Site Preparation Protocol During Dental Implant Placement. A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Density
Implant Stability
Keywords: hounsfield
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wo groups were made one test and control. The control group were treated with conventional implant site preparation technique and the test group were treated with osseodensification technique.
Primary purpose: TREATMENT

Brief summary: The present study is a human, prospective, randomised controlled clinical trial conducted to explore and compare the clinical and radiological outcome of Osseodensification protocol with conventional implant site preparation protocol. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed description: Twenty two dental implants were placed in twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients received Norris implant. the implant site preparation technique being Osseodensification protocol for the test group and conventional implant site preparation protocol for the control group, eleven in each group. The clinical and radiographic parameters were recorded at baseline, immediate post implant placement, six months and twelve months postoperatively.

Eligibility criteria: Inclusion Criteria:

1. Single/multiple missing teeth in the maxillary anterior/posterior region.
2. Bone density of D2 or D3 (Carl E.Misch).
3. Patients between 18-75 years.
4. Patients who demonstrate good plaque control (PI\<10%) and showing good compliance.
5. Patients willing to participate in the study.

Exclusion Criteria:-

1. Insufficient density or height of residual ridge.
2. Patients with bleeding disorder or on anticoagulant therapy.
3. Pregnant and lactating females.
4. Patients with history of smoking.
5. Use of systemic antibiotics in the past 3 months.
6. Patients treated with any medication known to cause periodontal changes.
7. Drug and alcohol abuse.
8. Occlusal interferences.
9. Patients with history of titanium allergy.
10. Immunocompromised state and debilitating disease.
11. Malignancy or radiotherapy/chemotherapy for malignancy.
12. Systemic diseases that would negatively influence wound healing.

Primary outcomes:
measure: primary implant stability
timeFrame: immediate post implant placement
measure: change from baseline in bone density
timeFrame: 1 year
measure: change from baseline in crestal bone level
timeFrame: 1 year
Secondary outcomes:
measure: change from baseline in keratinized mucosa width
timeFrame: 1 year
measure: change from baseline in ridge width
timeFrame: 1 year
measure: Patient reported pain evaluation (Visual Analog Scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Rajiv Gandhi University of Health Sciences
name: PRIYANKA ACHARYA, mds
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajiv Gandhi University of Health Sciences
name: prabhuji mlv, mds
role: STUDY_DIRECTOR
References:
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