Impact of implant placement timing on healing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how the timing of dental implant placement affects the healing process by comparing immediate and delayed implant placements. It aims to analyze changes in the expression of specific biomarkers related to inflammation, angiogenesis, and bone healing in saliva and peri-implant crevicular fluid over various time points. Conducted at two centers, the study will involve multiple visits over a minimum of 16 months to gather comprehensive data on healing outcomes. The findings could provide insights into optimizing implant protocols for better patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Centre for Oral Clinical Research
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Nikolaos Donos — Qmul
• Study coordinator: Miljana Bacevic
• Email: BHNT.Clinicaloralresearchcentre@nhs.net
• Phone: 02078823063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.