Surface change in tooth replacement implant to have long term success

Effect of Guided probiotic colonization of dental implants on clinical outcomes, early healing dynamics and long-term success through immune-regulation: a randomized controlled trial

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041780

Enrollment

Registered

2022-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: Guided Probiotic Colonization of Dental Implants: Dental Implants modified by culturing Lactobacillus reutari (probiotic) on its surface will be placed in the test subjects and healing

Eligibility

Inclusion criteria

Inclusion criteria: good general health non smokers or former smokers(not smoked within 6 months of study initiation) no chronic systemic diseases presence of hopeless teeth requiring extraction more than 3mm of bone beyond the root apex presence of four bony walls of the socket with or without dehiscence

Exclusion criteria

Exclusion criteria: presence of chronic systemic diseases bruxism habit uncontrolled diabetes coagulation disorders alcohol or drug abuse reduced compliance after oral hygiene sessions complete edentulism mucosal diseases pregnancy or lactation patients withholding consent for participation in the study

Design outcomes

Primary

Measure	Time frame
Early Wound Healing Dynamics by measuring following clinical parameters Modified plaque index Mobelli et al 1987 Modified sulcus bleeding index Muhlemann and son 1971 Probing pocket depth by UNC 15 probe Mucosa level Resonance frequency analysis by Osstell instrument Wound healing index by Wachtel et al 2003 and patient related outcomes by 5 point Likert type scale Osseointegration by crestal bone loss by long cone parallel technique Immune-regulation by M1 M2 cytokine profiling by ProcartaPlex Timepoint: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement	—

Measure

Time frame

Early Wound Healing Dynamics by measuring following clinical parameters Modified plaque index Mobelli et al 1987 Modified sulcus bleeding index Muhlemann and son 1971 Probing pocket depth by UNC 15 probe Mucosa level Resonance frequency analysis by Osstell instrument Wound healing index by Wachtel et al 2003 and patient related outcomes by 5 point Likert type scale Osseointegration by crestal bone loss by long cone parallel technique Immune-regulation by M1 M2 cytokine profiling by ProcartaPlex Timepoint: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement

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Secondary

Measure	Time frame
Study the long-term effect of GPC integrated implant in maintaining peri-implant disease free status compared to control groupTimepoint: Supportive implant maintenance protocol and would be evaluated for clinical and radiographical parameters at an interval of every 06 months after study completion. The long term-evaluation of implant survival, MBL and biological complications for at least 5 years after study completion	—

Measure

Time frame

Study the long-term effect of GPC integrated implant in maintaining peri-implant disease free status compared to control groupTimepoint: Supportive implant maintenance protocol and would be evaluated for clinical and radiographical parameters at an interval of every 06 months after study completion. The long term-evaluation of implant survival, MBL and biological complications for at least 5 years after study completion

—

Countries

India

Contacts

Public ContactDr Rameshwari Singhal

King Georges Medical University

rameshwarisinghal@kgmcindia.edu9837400562

Outcome results

None listed

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