Clinical trial NCT05834946: Biological Responses Affecting Early-stage Dental Implant Placement in Patients With History of Periodontitis
Official title: Identification of Biological Responses as a Causal Link for the Increased Peri-implantitis in Patients With History of Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Peri-implant Mucositis
Peri-Implantitis
Keywords: dental implant
history of periodontitis
matrix metalloproteinase (MMP)-8
histological analysis
next generation sequencing
dental plaque
gingival crevicular fluids
peri-implant sulcular fluids
peri-implant soft tissue
proteomic analysis
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group: Patient with history of periodontitis Control group: Patient without history of periodontitis

Patients in both groups will be randomised to receive one of two type of implants with different surface characteristics.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: This is a prospective, parallel, double-blind, four-arm randomised clinical control study, aims to investigate the changes of clinical parameters and pro-inflammatory biomarkers expression and the shift following the first dental implant placement in patients who have been successfully treated for periodontitis, compared with healthy control without the disease.

The main questions to answer are:

1. Why do patients with history of periodontitis are at a greater risk to develop peri-implantitis than patients without history of periodontitis?
2. Is there any difference in the microbial composition, histological and immunological reaction of the host's dental plaque, peri-implant soft tissue, gingival crevicular fluids (GCF) of adjacent teeth and peri-implant sulcular fluids (PISF) following implant placement in patients with and without a history of periodontitis? The test group will consist of subjects with stabilised periodontitis, whilst the control group will consist of healthy patients with no history of periodontitis, as identified via history taking and clinical screening. Periodontal condition will be determined based on the new 2017 periodontal classification. All participants in both groups will be randomised to receive one of two types of implants with different surface treatment.

Clinical measurement, GCF and PISF will be collected around the single implant and adjacent teeth, at the following stages (time-point):

* Baseline (pre-operative)
* After implant placement (prior to the second stage surgery)
* After implant exposure (prior to the crown restoration)
* 3-month after the implant is restored
* Soft tissue will be obtained during the first stage (baseline) and second stage implant surgery (post-operative) and analysed.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of matrix metalloproteinase (MMP)-8 expressed in the gingival crevicular and peri-implant sulcular fluids during the early-stage of dental implant placement
timeFrame: 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:
measure: Shift of the microbial composition in the supragingival dental plaque, identified via 16S rRNA next generation sequencing
timeFrame: 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)
measure: Shift of proteome profiles in the gingival crevicular and peri-implant sulcular fluids during the early-stage of dental implant placement
timeFrame: 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)
measure: Histological changes in the peri-implant soft tissue before and after implant placement
timeFrame: Between first stage (baseline/pre) and second stage implant surgery (post-operative) at 3 months after the first surgery
measure: Changes in the clinical parameters during the early-stage implant placement
timeFrame: 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)
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry, University of Malaya
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Norul H Mohamad-Hassan, DDS,MCD
role: PRINCIPAL_INVESTIGATOR
References: