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A clinical trial to study microbial growth following placement of different sealing materials in dental implants

Microbial assessment & quantification following placement of different sealing materials at the screw abutment connection under loading conditions in dental implants A metagenomic study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049252
Enrollment
100
Registered
2023-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: K081- Complete loss of teeth Health Condition 2: K038- Other specified diseases of hard tissues of teeth

Interventions

Intervention1: Temporary composite material: temporary composite material to be inserted in implant abutment connection for duration of 03 months. Intervention2: Polytetraflouroethylene tape: PTFE tap

Sponsors

Sarah Mariam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Immediate implant placement or delayed implant placement in adult population more than 18 years of age for both gender. 2. Edentulism in mandibular molar area. 3. B and B implant system to be used in the study. 4. Abutment type - internal hexagon connection. 5. Screw retained prosthesis with access hole.

Exclusion criteria

Exclusion criteria: 1. Other implant system. 2. Abutment type other than internal hexagon connection. 3. Cement retained prosthesis. 4. Patient suffering from any uncontrolled systemic condition 5. Patient suffering from active periodontal disease, or if patient has undergone any periodontal treatment in past 06 months.

Design outcomes

Primary

MeasureTime frame
Immediate i. Material which contains largest quantity of oral microbes can be avoided since it can affect the success rate of implants. ii. Metagenomic study can help us know specific microbial niches which form part of specific materials. Long term i. Since the success rate of implant is 90% for 10 years and 80% for next 10 years IMPLANT MAINTENANCE is important. ii. The present study is clinically relevant as changing material at screw-abutment connection forms an important protocol in follow up. iii. The best material which supports the least microbiome forms part of long term expected outcomes. Timepoint: Recruitment-one year Metagenomic analysis- two years—

Secondary

MeasureTime frame
Long term i. Since the success rate of implant is 90% for 10 years and 80% for next 10 years IMPLANT MAINTENANCE is important. ii. The present study is clinically relevant as changing material at screw-abutment connection forms an important protocol in follow up. iii. The best material which supports the least microbiome forms part of long term expected outcomes. Timepoint: Recruitment- one year Metagenomic analysis: 02 year secondary outcomes: 1 year—

Countries

India

Contacts

Public Contactsarah mariam

Bharati vidyapeeth deemed to be university dental college and hospital, Pune

sarah.mariam@bharatividyapeeth.edu

Outcome results

None listed

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