Influence of Timing of Implant Placement on Early Healing Molecular Events

NCT06276335 | Recruiting

• 1 other identifier: IRAS:322440
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Dental Implant; Healing Wound; Biomarkers; Saliva

Keywords

Implant placement protocol

Outcome Measures

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

  1, 3, 7, 15 and 30 days after immediate or delayed implant placement

Secondary Outcomes (14)

• Blood flow changes

  immediately after, 1, 3, 7, 15 and 30 days after immediate or delayed implant placement

• Soft tissue volume changes

  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

  6 months after implant loading

• Full mouth plaque score (FMPS)

  6 months after implant loading

• Full mouth bleeding score (FMBS)

  6 months after implant loading

Study Arms (2)

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

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

Other: Late implant placement and guided bone regeneration (Control)

Interventions

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.

Immediate implant placement and conventional loading (Test)

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).

Late implant placement and conventional loading (Control)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• University of Belgrade: collaborator

Study Sites (1)

Centre for Oral Clinical Research

London, E1 2AD, United Kingdom

RECRUITING

Study Officials

• Nikolaos Donos

  QMUL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miljana Bacevic

CONTACT

02078823063; BHNT.Clinicaloralresearchcentre@nhs.net

Jeniffer Perussolo

CONTACT

02078823063; BHNT.Clinicaloralresearchcentre@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

GB (1)