Dental ImplantNCT06276335
Influence of Timing of Implant Placement on Early Healing Molecular Events
A study testing Immediate implant placement and guided bone regeneration (Test) in people with Dental Implant and Healing Wound, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Dental Implant, Healing Wound, Biomarkers
- What is being tested?
- Immediate implant placement and guided bone regeneration (Test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Centre for Oral Clinical Research
London, E1 2AD
Nikolaos Donos, DDS MS PhD, +44(0)2078823063, BHNT.Clinicaloralresearchcentre@nhs.net
Miljana Bacevic, Dr, +44(0)2078826348, BHNT.Clinicaloralresearchcentre@nhs.net
About this study
Official title: Influence of Timing of Implant Placement on Early Healing Molecular Events: A Two-centre, Parallel Group, Pilot Study
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).
Read the detailed description
This is a two-centre prospective, parallel-group pilot study which will consist of 10 to 11 visits over a minimum period of 16 months. The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London (main centre), United Kingdom and at the Implant Research Centre, School of Dental Medicine, University of Belgrade, in accordance with local guidelines and procedures/ interventions detailed below.
- Conditions
- Dental Implant, Healing Wound, Biomarkers, Saliva
- Being tested
- Immediate implant placement and guided bone regeneration (Test), Late implant placement and guided bone regeneration (Control)
- Keywords
- Implant placement protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement and guided bone regeneration (Test)Other
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)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement and conventional loading (Test) | Experimental | In this group, a dental implant will be placed on the same day as tooth extraction and loaded after 3 months Receives: Other: Immediate implant placement and guided bone regeneration (Test) |
| Late implant placement and conventional loading (Control) | Active comparator | In this group, a dental implant will be placed after complete bone healing (4 - 6 months after tooth extraction) and loaded after 3 months Receives: Other: Late implant placement and guided bone regeneration (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1, 3, 7, 15 and 30 days after immediate or delayed implant placement
Secondary outcomes (14)
Blood flow changes
Blood flow changes immediately after, at 1, 3, 7, 15 and 30 days after implant placement
Measured: immediately after, 1, 3, 7, 15 and 30 days after immediate or delayed implant placement
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
Measured: immediately after,1, 3, 7, 15, 30 days and 3 months after immediate or delayed implant placement, at loading and 6 months after implant loading
Peri-implant bone level
Peri-implant bone level 6 months after loading, using CBCT images
Measured: 6 months after implant loading
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).
Measured: 6 months after implant loading
Full mouth bleeding score (FMBS)
FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).
Measured: 6 months after implant loading
Probing pocket depth (PPD)
PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/ implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).
Measured: 6 months after implant loading
Gingival recession (REC)
REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/ implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).
Measured: 6 months after implant loading
Clinical attachment level (CAL)
CAL will be calculated considering the values for PPD and REC in mm
Measured: 6 months after implant loading
Suppuration
Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent).
Measured: 6 months after implant loading
Patient satisfaction at 6 months after loading
Patient satisfaction regarding the overall implant treatment using a subjective outcome questionnaire at 6 months post loading.
Measured: 6 months after implant loading
Changes in the pink esthetic score (PES)
Changes in the pink esthetic score (PES) from loading to 6 months after loading
Measured: 6 months after implant loading
Changes in the white esthetic score (WES)
Changes in the white esthetic score (WES) from loading to 6 months after loading
Measured: 6 months after implant loading
Changes in the papilla fill index (PFI)
Changes in the papilla fill index (PFI) from loading to 6 months after loading
Measured: 6 months after implant loading
Implant survival
Implant functionally present in the mouth
Measured: 6 months after implant loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start26 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Sponsor
- Investigators
- Nikolaos Donos, Principal investigator, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276335
- Sponsor's protocol ID
- IRAS:322440
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Timing of Implant Placement on Early Healing Molecular Events: A Two-centre, Parallel Group, Pilot Study
- ClinicalTrials.gov ID
- NCT06276335
- Acronym / sponsor ID
- IRAS:322440
- Conditions
- Dental Implant, Healing Wound, Biomarkers, Saliva
- Keywords
- Implant placement protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Feb 2024 (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.
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).
Detailed description
This is a two-centre prospective, parallel-group pilot study which will consist of 10 to 11 visits over a minimum period of 16 months. The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London (main centre), United Kingdom and at the Implant Research Centre, School of Dental Medicine, University of Belgrade, in accordance with local guidelines and procedures/ interventions detailed below.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement and conventional loading (Test) | Experimental | Other: Immediate implant placement and guided bone regeneration (Test)In this group, a dental implant will be placed on the same day as tooth extraction and loaded after 3 months |
| Late implant placement and conventional loading (Control) | Active comparator | Other: Late implant placement and guided bone regeneration (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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (16 listed)
- 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.
- 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).
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 |
|---|---|---|
| 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. | Other | Immediate implant placement and conventional loading (Test) |
| 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). | Other | Late implant placement and conventional loading (Control) |
Primary outcome
Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva
Time frame: 1, 3, 7, 15 and 30 days after immediate or delayed implant placement
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
14 secondary outcomes
Blood flow changes
Time frame: immediately after, 1, 3, 7, 15 and 30 days after immediate or delayed implant placement
Soft tissue volume changes
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 loading
Peri-implant bone level
Time frame: 6 months after implant loading
Full mouth plaque score (FMPS)
Time frame: 6 months after implant loading
Full mouth bleeding score (FMBS)
Time frame: 6 months after implant loading
Probing pocket depth (PPD)
Time frame: 6 months after implant loading
Gingival recession (REC)
Time frame: 6 months after implant loading
Clinical attachment level (CAL)
Time frame: 6 months after implant loading
Suppuration
Time frame: 6 months after implant loading
Patient satisfaction at 6 months after loading
Time frame: 6 months after implant loading
Changes in the pink esthetic score (PES)
Time frame: 6 months after implant loading
Changes in the white esthetic score (WES)
Time frame: 6 months after implant loading
Changes in the papilla fill index (PFI)
Time frame: 6 months after implant loading
Implant survival
Time frame: 6 months after implant loading
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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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.
Nikolaos Donos principal investigator
QMUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement and guided bone regeneration (Test) in people with Dental Implant and Healing Wound, run by Queen Mary University of London at 1 site in United Kingdom.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miljana Bacevic (02078823063, BHNT.Clinicaloralresearchcentre@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva (time frame: 1, 3, 7, 15 and 30 days after immediate or delayed implant placement). 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 1 Sep 2026.