Periodontitis Clinical Trial
Official title:
Identification of Biological Responses as a Causal Link for the Increased Peri-implantitis in Patients With History of Periodontitis
Verified date | April 2023 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 29 |
Est. completion date | May 30, 2025 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Specific inclusion criteria for test group: - History of periodontitis but currently stable - Must have successfully completed active periodontal treatment at least 4 months prior to the commencement of study 2. Specific inclusion criteria for control group: - No history of periodontitis, with minimal age-related radiographic bone loss - Reason for losing the tooth/teeth was not due to periodontal problem 3. General inclusion criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Faculty of Dentistry, University of Malaya | Kuala Lumpur | Wilayah Persekutuan |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Shift of the microbial composition in the supragingival dental plaque, identified via 16S rRNA next generation sequencing | Identification and comparison of supragingival dental plaque bacteria species/genus and the shift of the bacterial composition during the early-stage of dental implant placement between study groups | 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) | |
Secondary | Shift of proteome profiles in the gingival crevicular and peri-implant sulcular fluids during the early-stage of dental implant placement | To assess the protein profile and levels of expression of the pro-inflammatory cytokines in GCF and gingival tissue via liquid chromatography-electrospray ionization tandem mass spectrometry (LC-MS) proteomic analysis following osseointegration. | 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) | |
Secondary | Histological changes in the peri-implant soft tissue before and after implant placement | Number and co-localisation of cells with MMP-8, pro-inflammatory (M1)- and anti-inflammatory (M2)-related cytokines via hematoxylin and eosin staining, immunohistochemistry and immunofluorescence analysis | Between first stage (baseline/pre) and second stage implant surgery (post-operative) at 3 months after the first surgery | |
Secondary | Changes in the clinical parameters during the early-stage implant placement | To assess intra-oral clinical parameters changes (i.e. patient-level and tooth-level mean periodontal pocket depth (mm) and clinical attachment level (mm); full mouth plaque score (%) and bleeding score (%)) following the first dental implant placement, each time-point (TP). The deeper the depth/higher the level or percentage means the worse the condition is. | 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) |
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