Soft Tissue Changes Around Dental Implants

Wound Heal Clinical Trial

— Geistlich  

Official title:

Dimensional Soft Tissue Changes Around Dental Implants Following the Use of a Collagen Matrix or a Connective Tissue Graft. A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265768
• Other study ID #: IRAS 268553
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: September 3, 2024

Study information

• Verified date: May 2023
• Source: Queen Mary University of London
• Contact: Elena Calciolari, PhD
• Phone: +44(0)207 882 3134
• Email: elena.calciolari[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases
• Tooth Loss
• Wound Heal

Intervention

Procedure:
• Soft tissue augmentation surgery with CTG
An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm). The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth.
• Soft tissue augmentation surgery with Fibro-Gide
Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.
• No soft tissue augmentation
During implant placement surgery, no soft tissue augmentation will be performed

Locations

Country	Name	City	State
United Kingdom	Barts and The London Dental Hospital	London
United Kingdom	Centre for Oral Clinical Research (COCR)	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Geistlich Pharma AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D intra-oral volume changes in mucosal soft tissue following augmentation	Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.	Immediately after implant placement.
Primary	3D intra-oral volume changes in mucosal soft tissue following augmentation	Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.	7, 14 and 30 Days post implant placement
Primary	3D intra-oral volume changes in mucosal soft tissue following augmentation	Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.	12 weeks and 16 weeks post- implant loading.
Primary	3D intra-oral volume changes in mucosal soft tissue following augmentation	Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.	12 month post- implant loading.
Secondary	Changes in gingival thickness	Changes in gingival thickness from the time of implant placement (with or without graft) and 12 weeks after implant placement assessed by a caliper	implant placement to 12 weeks after implant placement
Secondary	3D extra-oral volumetric changes	3D extra-oral morphometric changes assessed with a facial scanner	baseline, immediately after implant placement, 7, 14 and 30 days after implant placement
Secondary	2D-3D intra-oral thermal changes	2D-3D intra-oral thermal changes using an infrared, contact-free, thermal camera	baseline to 1, 3, 7, 14 and 30 days after implant placement
Secondary	changes in vascularisation	Changes in revascularization in the area of the implant surgery with laser speckle contrast imaging	before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30
Secondary	soft tissue aesthetics	Papilla Fill Index and Pink Aesthetic Score	At implant loading and at 12 months after loading.
Secondary	changes in height of keratinised tissue	changes in height of keratinised tissue measured with a probe	baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading
Secondary	Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP)	The OIPD is a well validated and frequently used PROMs in studies of oral health. It is a composite measure of the impacts of oral health on the quality of life of people. The OIDP focuses on the impact of oral health on the quality of life of people. The OIDP focuses on the impact that the conditions of the teeth and social wellbeing of the person. More specifically, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.	At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Secondary	PROMs based on the evaluation of global changes in quality of life	Global ratings on health and quality of life will be provided through two methods: The Visual Analogue Scale (VAS) included in the EQ5D questionnaire.; Through the following question: 'how would you rate the quality of your life'?; The response will be scored on a six-point scale as: Excellent; Very good; Good; Fair; Poor; Very poor	At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Secondary	PROMs based on the evaluation of patient's perception about therapy	The extent of discomfort and/or pain experienced will be evaluated using a 100-mm horizontal visual analogue scale (VAS). The anchors for each end of the scales will be designated as none and extreme. Patients will be also instructed to quantify the analgesic medication taken. In addition, the extent of discomfort, root hypersensitivity, oedema, hematoma, high fever and interference in daily activities during the first post-therapy week will be evaluated in the same way.	At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Secondary	Post-operative swelling and oedema	A series of subtracted images from the baseline will accurately identify the area and magnitude of the swelling, changes in facial shape, volume and temperature to monitor/quantify the healing. For every patient, a person specific template of postoperative facial swelling/oedema pattern will be created for sequential swelling/thermal changes or oedema volume measurements that will be applied on a unique alignment of the patient's specific consecutive imaging surfaces (self-defined positioning based on patients facial features).	At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.