Biological Responses Affecting Early-stage Dental Implant Placement in Patients With History of Periodontitis
Identification of Biological Responses as a Causal Link for the Increased Peri-implantitis in Patients With History of Periodontitis
1 other identifier
interventional
29
1 country
1
Brief Summary
This prospective parallel, double-blind, four-arm randomised controlled clinical study is planned to assess the difference in the level of the inflammatory biomarkers expressed following the placement of the first dental implant in patients with history of periodontitis (successfully treated) and healthy controls without the disease, during implant osseointegration period. The subjects in both groups will also be randomised to receive one of the two types of implants provided which have different surface treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2021
CompletedFirst Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedOctober 18, 2023
April 1, 2023
2.2 years
January 17, 2023
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of matrix metalloproteinase (MMP)-8 expressed in the gingival crevicular and peri-implant sulcular fluids during the early-stage of dental implant placement
To measure the absolute quantification of MMP-8 level expressed during the implant osseointegration period in all study groups via ELISA method.
From baseline (1st time-point (TP1)) to 1st stage surgery (implant placement - TP2), after 2nd stage surgery (implant exposure (TP3) and 3-months after implant crown restoration (final visit- TP4)
Secondary Outcomes (4)
Shift of the microbial composition in the supragingival dental plaque, identified via 16S rRNA next generation sequencing
From baseline (1st time-point (TP1)) to 1st stage surgery (implant placement - TP2), after 2nd stage surgery (implant exposure (TP3) approximately 3 months after the 1st stage surgery) and 3-months after implant crown restoration (final visit- TP4)
Shift of proteome profiles in the gingival crevicular and peri-implant sulcular fluids during the early-stage of dental implant placement
From baseline (1st time-point (TP1)) to 1st stage surgery (implant placement - TP2), after 2nd stage surgery (implant exposure (TP3) approximately 3 months after the 1st stage surgery) and 3-months after implant crown restoration (final visit- TP4)
Histological changes in the peri-implant soft tissue before and after implant placement
Between first stage (baseline/pre) and second stage implant surgery (post-operative) at 3 months after the first surgery
Changes in the clinical parameters during the early-stage implant placement
From baseline (1st time-point (TP1)) to 1st stage surgery (implant placement - TP2), after 2nd stage surgery (implant exposure (TP3) approximately 3 months after the 1st stage surgery) and 3-months after implant crown restoration (final visit- TP4)
Study Arms (4)
Group T-A
EXPERIMENTAL7 patients with history of periodontitis
Group T-B
EXPERIMENTAL7 patients with history of periodontitis
Group C-A
ACTIVE COMPARATOR7 patients without history of periodontitis
Group C-B
ACTIVE COMPARATOR8 patients without history of periodontitis
Interventions
Megagen implant with sand-blasted, large-grit, acid-etched (SLA) and nano-calcium ions incorporated surface
Biomate-Swiss implant with precision dimension laser (PDL) surface
Eligibility Criteria
You may qualify if:
- History of periodontitis but currently stable
- Must have successfully completed active periodontal treatment at least 4 months prior to the commencement of study
- No history of periodontitis, with minimal age-related radiographic bone loss
- Reason for losing the tooth/teeth was not due to periodontal problem
- Medically healthy
- Aged between 30 to 65 years old
- Non-smoker, or quit smoking at least 12 months before study commencement
- Good oral hygiene (full mouth plaque score (FMPS)\<20%, full mouth bleeding score (FMBS)\<15%)
- Indicated for a single implant placement in the posterior region, with adjacent and contralateral natural tooth
- Intact inter-cuspal position
You may not qualify if:
- Previous history of dental implant placement
- Currently pregnant or intend to be pregnant, and/or lactating mothers
- Taking long-term medicines which may affect gingival tissue and oral microbiome, e.g. antibiotics, anticoagulants, anticonvulsants, immunosuppressants and calcium channel blockers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norul H Mohamad-Hassan, DDS,MCD
University of Malaya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- All participants will be blinded from the randomisation. An opaque envelope will be used to conceal the implant designation and will only be revealed to the operator after the site is ready for implant placement. A blinded researcher will be assigned as clinical assessor who will not be involved with the surgical procedure, subject recruitment nor consent taking. An assistant who is not involved with the research will also be asked to re-code the sample tubes to ensure blinding for data/sample analysis.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
April 28, 2023
Study Start
March 4, 2021
Primary Completion
May 30, 2023
Study Completion
May 30, 2025
Last Updated
October 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 3 months and ending 5 years following article(s) publication.
- Access Criteria
- To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement.
Individual participant data that underlie the results reported in this article after deidentification. Researchers should provide a methodologically sound proposal and directed to the principal investigator by email.