PeriodontitisNCT05834946
Biological Responses Affecting Early-stage Dental Implant Placement in Patients With History of Periodontitis
A study testing Megagen implant placement and Biomate-Swiss implant in people with Periodontitis and Peri-implant Mucositis, run by University of Malaya at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Peri-implant Mucositis, Peri-Implantitis
- What is being tested?
- Megagen implant placement and Biomate-Swiss implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 Mar 2021to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: Identification of Biological Responses as a Causal Link for the Increased Peri-implantitis in Patients With History of Periodontitis
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.
Read the 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:
- Why do patients with history of periodontitis are at a greater risk to develop peri-implantitis than patients without history of periodontitis?
- 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.
- Conditions
- Periodontitis, Peri-implant Mucositis, Peri-Implantitis
- Being tested
- Megagen implant placement, Biomate-Swiss implant
- 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
- Medical subject headings
- Periodontitis, Peri-Implantitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megagen implant placementOther
Megagen implant with sand-blasted, large-grit, acid-etched (SLA) and nano-calcium ions incorporated surface
Biomate-Swiss implantOther
Biomate-Swiss implant with precision dimension laser (PDL) surface
| Study group | Role | What they receive |
|---|---|---|
| Group T-A | Experimental | 7 patients with history of periodontitis Receives: Other: Megagen implant placement |
| Group T-B | Experimental | 7 patients with history of periodontitis Receives: Other: Biomate-Swiss implant |
| Group C-A | Active comparator | 7 patients without history of periodontitis Receives: Other: Megagen implant placement |
| Group C-B | Active comparator | 8 patients without history of periodontitis Receives: Other: Biomate-Swiss implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start4 Mar 2021
- Primary completion30 May 2023
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norul H Mohamad-Hassan, DDS,MCD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834946
- Sponsor's protocol ID
- DF RD2002/0002
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biological Responses as a Causal Link for the Increased Peri-implantitis in Patients With History of Periodontitis
- ClinicalTrials.gov ID
- NCT05834946
- Acronym / sponsor ID
- DF RD2002/0002
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Why do patients with history of periodontitis are at a greater risk to develop peri-implantitis than patients without history of periodontitis?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group T-A | Experimental | Other: Megagen implant placement7 patients with history of periodontitis |
| Group T-B | Experimental | Other: Biomate-Swiss implant7 patients with history of periodontitis |
| Group C-A | Active comparator | Other: Megagen implant placement7 patients without history of periodontitis |
| Group C-B | Active comparator | Other: Biomate-Swiss implant8 patients without history of periodontitis |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Specific inclusion criteria for test group:
- Specific inclusion criteria for control group:
- General inclusion criteria:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megagen implant placementMegagen implant with sand-blasted, large-grit, acid-etched (SLA) and nano-calcium ions incorporated surface | Other | Group C-A, Group T-A |
| Biomate-Swiss implantBiomate-Swiss implant with precision dimension laser (PDL) surface | Other | Group C-B, Group T-B |
Primary outcome
Level of matrix metalloproteinase (MMP)-8 expressed in the gingival crevicular and peri-implant sulcular fluids during the early-stage of dental implant placement
Time frame: 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)
To measure the absolute quantification of MMP-8 level expressed during the implant osseointegration period in all study groups via ELISA method.
4 secondary outcomes
Shift of the microbial composition in the supragingival dental plaque, identified via 16S rRNA next generation sequencing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norul H Mohamad-Hassan, DDS,MCD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Megagen implant placement and Biomate-Swiss implant in people with Periodontitis and Peri-implant Mucositis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.