Influence of Timing of Implant Placement on Early Healing Molecular Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorQueen Mary University of London
About this trial
Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP).
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥25 years old
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.
Disqualifiers
Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Immediate implant placement and guided bone regeneration (Test)
Other interventionIn 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)
Other interventionA 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).
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Immediate implant placement and conventional loading (Test)Experimental treatment 1 intervention
Group B: Late implant placement and conventional loading (Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva
The expression of inflammatory, angiogenesis and osseous biomarkers of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) or delayed placement (DP) and of saliva at day 1, 3, 7, 15 and 30
Time frame
1, 3, 7, 15 and 30 days after immediate or delayed implant placementSecondary outcomes
1
Blood flow changes
Blood flow changes immediately after, at 1, 3, 7, 15 and 30 days after implant placement
Time frame
immediately after, 1, 3, 7, 15 and 30 days after immediate or delayed implant placement2
Soft tissue volume changes
Soft tissue volume changes immediately after, at 1, 3, 7, 15, 30 days and 3 months after immediate or delayed implant placement, at loading and 6 months after implant loading
Time frame
immediately after,1, 3, 7, 15, 30 days and 3 months after immediate or delayed implant placement, at loading and 6 months after implant loading3
Peri-implant bone level
Peri-implant bone level 6 months after loading, using CBCT images
Time frame
6 months after implant loading4
Full mouth plaque score (FMPS)
FMPS will be recorded as a percentage of total surfaces (6 sites per tooth/implant), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).
Time frame
6 months after implant loadingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
University of Belgrade
Collaborator
Source ClinicalTrials.gov