Clinical trial NCT04265768: Soft Tissue Changes Around Dental Implants
Official title: Dimensional Soft Tissue Changes Around Dental Implants Following the Use of a Collagen Matrix or a Connective Tissue Graft. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Dental Diseases
Wound Heal
Keywords: soft tissue regeneration
soft tissue graft
dental implant
imaging
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2020-02-12
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will includes 3 groups randomised in parallel.
Primary purpose: TREATMENT

Brief summary: This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.

Detailed description: This study will characterize, for the first time, the healing pattern of soft tissues around dental implants in case of soft tissue augmentation and in comparison, to normal healing.

An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way.

This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts.

Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 80 years.
* Good medical and psychological health.
* Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this has to be arranged outside the study protocol and completed at least 30 days prior to the enrolment.
* Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region.
* Presence of adequate bone for implant placement without need for significant bone regeneration. In particular, the patients should have a bucco-palatal residual alveolar width of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone (De Bruyckere et al., 2018).
* A residual alveolar height \>8 mm, enough inter-arch space for a crown and a minimum distance of 6 mm from the adjacent teeth.
* The width and height will be confirmed after x-ray examination in Visit 1 (or extra visit). Cases of small apical fenestration (≤ 25% of implant length) after implant placement will not be excluded, but will be treated according to the GBR principle (collagen membrane associated with a deproteinized bovine bone graft) to re-establish the bone contour and without over contouring.
* At least 8 weeks of post-extraction socket healing had occurred in the edentulous site.
* Willingness to sign the informed consent form.

Exclusion Criteria:

* Self-reported pregnancy and lactation.
* Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation.
* Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
* HIV or viral hepatitis.
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
* Self-reported alcoholism or chronic drug abuse.
* Heavy smokers (\>10/cigarettes per day).
* 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 be obtained or simple instructions could be followed.
* Full-mouth bleeding (BOP) and plaque (PI) scores \>30% or sites with periodontal pocket depth \>5 mm at the completion of the pre-treatment phase.
* Very thin or very thick biotypes that according to the clinician's judgement would either risk to have complications or would not benefit from receiving a graft.
* \<2 mm KT buccally (from the mucogingival junction to the coronal aspect of the crestal soft tissue).

Primary outcomes:
measure: 3D intra-oral volume changes in mucosal soft tissue following augmentation
timeFrame: Immediately after implant placement.
measure: 3D intra-oral volume changes in mucosal soft tissue following augmentation
timeFrame: 7, 14 and 30 Days post implant placement
measure: 3D intra-oral volume changes in mucosal soft tissue following augmentation
timeFrame: 12 weeks and 16 weeks post- implant loading.
measure: 3D intra-oral volume changes in mucosal soft tissue following augmentation
timeFrame: 12 month post- implant loading.
Secondary outcomes:
measure: Changes in gingival thickness
timeFrame: implant placement to 12 weeks after implant placement
measure: 3D extra-oral volumetric changes
timeFrame: baseline, immediately after implant placement, 7, 14 and 30 days after implant placement
measure: 2D-3D intra-oral thermal changes
timeFrame: baseline to 1, 3, 7, 14 and 30 days after implant placement
measure: changes in vascularisation
timeFrame: before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30
measure: soft tissue aesthetics
timeFrame: At implant loading and at 12 months after loading.
measure: changes in height of keratinised tissue
timeFrame: baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading
measure: Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP)
timeFrame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
measure: PROMs based on the evaluation of global changes in quality of life
timeFrame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
measure: PROMs based on the evaluation of patient's perception about therapy
timeFrame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
measure: Post-operative swelling and oedema
timeFrame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and The London Dental Hospital
city: London
country: United Kingdom
facility: Centre for Oral Clinical Research (COCR)
Study officials:
affiliation: Barts & The London School of Medicine & Dentistry, QMUL
name: Nikos Donos, PhD
role: PRINCIPAL_INVESTIGATOR
References: