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Clinical Trials/CTRI/2024/11/077050
CTRI/2024/11/077050RecruitingNot Applicable

Clinico-radiographic comparison of peri implant tissue after implant site osteotomy using irrigation solution at two different temperatures: A randomized controlled trial

Rukhshana Khatoon1 site in 1 country20 target enrollmentStarted: November 25, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Level of alveolar bone crest of control and intervention group.

Study Overview

Brief Summary

The trial will primarily perform in the department of periodontology and oral implantology UDMRI Dehradun in which we will perform prosthetically driven surgical modality that is dental implant surgery. Traditionally this procedure is performed using irrigation solution which is at room temperature (26°C to 30°C). In this study we are considering to change the temperature of irrigation solution to colder conditions (4°C to 8°C). We will observe crestal bone level before placement of dental implant and after 6 months of implant placement in both groups. Additionally, we will observe the crestal bone levels at 3 months after implant placement. We will also observe clinical change around the implants during this trial and will report the observations.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • healthy Indian patient 2) partially edentulous 3) enough bone height/width for implant placement 4) ready to come for 6-month recall.

Exclusion Criteria

  • Active Periodontal Infection (no periodontal pocket depth greater than 3 mm at the time of implant placement).
  • unresolved extraction wounds or inadequate bone at the time of implant placement 3) lack of motivation and/or compliance 4) moderate/heavy smoking 5) uncontrolled diabetes mellitus 6) bruxism 7) a medical condition that contraindicates surgery 8) pregnancy.

Outcomes

Primary Outcomes

Level of alveolar bone crest of control and intervention group.

Time Frame: 6 months

Secondary Outcomes

  • Level of alveolar bone crest of control group.(Baseline)
  • Level of alveolar bone crest of control group(3 months)
  • Level of alveolar bone crest of intervention group.(Baseline)
  • Level of alveolar bone crest of intervention group(3 months)
  • Clinical changes around implant placed.(3 months.)
  • Clinical changes around implant placed(6 months)

Investigators

Sponsor
Rukhshana Khatoon
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rukhshana Khatoon

Uttaranchal Dental and Medical Research Institute

Study Sites (1)

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