Influence of Timing of Implant Placement on Early Healing Molecular Events
NCT ID: NCT06276335
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2024-09-26
2026-12-31
Brief Summary
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The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Immediate implant placement and conventional loading (Test)
In this group, a dental implant will be placed on the same day as tooth extraction and loaded after 3 months
Immediate implant placement and guided bone regeneration (Test)
In this group, immediately after tooth extraction, a tapered bone level implant (Straumann BLX Implant System, Roxolid, Straumann AG, Basel, Switzerland) will be placed in an ideal prosthetically oriented position to achieve primary stability following the manufacture's guidelines. A prefabricated surgical template based on 3D pre-extraction planning will be used to place the implant. The jumping distance between the implant and the residual buccal bone will be measured and filled with slow resorption bone graft material (Bio-Oss®, Geistlich, Wolhusen, Switzerland) as per standard of practice.
Late implant placement and conventional loading (Control)
In this group, a dental implant will be placed after complete bone healing (4 - 6 months after tooth extraction) and loaded after 3 months
Late implant placement and guided bone regeneration (Control)
A tapered bone level implant (Straumann BLX Implant System, Roxolid, Straumann AG, Basel, Switzerland) will be placed after complete bone healing (4 - 6 months after tooth extraction) in an ideal prosthetically oriented position to achieve primary stability following the manufacture's guidelines. Guided bone regeneration (GBR) will be performed simultaneously with the aim to re-establish the bone contour and treat any fenestration/dehiscence if needed. A bovine osteoconductive graft (Bio-Oss®, Geistlich, Wolhusen, Switzerland) will be loosely compacted on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).
Interventions
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Immediate implant placement and guided bone regeneration (Test)
In this group, immediately after tooth extraction, a tapered bone level implant (Straumann BLX Implant System, Roxolid, Straumann AG, Basel, Switzerland) will be placed in an ideal prosthetically oriented position to achieve primary stability following the manufacture's guidelines. A prefabricated surgical template based on 3D pre-extraction planning will be used to place the implant. The jumping distance between the implant and the residual buccal bone will be measured and filled with slow resorption bone graft material (Bio-Oss®, Geistlich, Wolhusen, Switzerland) as per standard of practice.
Late implant placement and guided bone regeneration (Control)
A tapered bone level implant (Straumann BLX Implant System, Roxolid, Straumann AG, Basel, Switzerland) will be placed after complete bone healing (4 - 6 months after tooth extraction) in an ideal prosthetically oriented position to achieve primary stability following the manufacture's guidelines. Guided bone regeneration (GBR) will be performed simultaneously with the aim to re-establish the bone contour and treat any fenestration/dehiscence if needed. A bovine osteoconductive graft (Bio-Oss®, Geistlich, Wolhusen, Switzerland) will be loosely compacted on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).
Eligibility Criteria
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Inclusion Criteria
* Good/controlled medical and psychological health
* Good oral hygiene (FMPS≤20%)
* Presence of a tooth in the aesthetic region (from incisor to second premolar) in need of extraction and further oral rehabilitation with a single dental implant.
* For the IP group, the extraction socket should fulfil the following parameters, as described by the 5th ITI consensus \[46\]: intact socket wall; facial bone wall ≥1mm in thickness; no acute infection at the site; availability of bone apical and palatal to the socket to provide primary stability.
* At least one neighbouring natural tooth.
* A functional occlusion with a minimum of four occlusal units (i.e., pairs of occluding posterior teeth).
* Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered.
Exclusion Criteria
* Self-reported HIV or viral hepatitis.
* Self-reported alcoholism or chronic drug abuse.
* Smokers (including current smokers or former smokers who had quit for \< 3 months); patients reporting use of vape/e-cigarettes will also be excluded.
* Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results).
* Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
* Chronic treatment with anticoagulants (including Aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation/count.
* Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam.
* Untreated caries lesions and untreated/uncontrolled periodontal disease; If patients require periodontal treatment (non-surgical and/or surgical), this will be arranged outside the study protocol and completed prior to enrolment;
* Inadequate keratinized tissue width (\<2 mm) in the mid-buccal aspect of the area to be treated in the study.
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement.
* Patients requiring maxillary sinus lift surgery before implant placement.
* Self-reported bruxism.
* Patients not willing to receive animal-derived biomaterials for GBR.
* Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
25 Years
ALL
No
Sponsors
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University of Belgrade
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Nikolaos Donos
Role: PRINCIPAL_INVESTIGATOR
QMUL
Locations
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Centre for Oral Clinical Research
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS:322440
Identifier Type: -
Identifier Source: org_study_id
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