Soft Tissue Changes Around Dental Implants (Geistlich)

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

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

Study Overview

• Status: Recruiting
• Conditions: Tooth Loss; Wound Heal; Dental Diseases
• Intervention / Treatment: Procedure: No soft tissue augmentation; Procedure: Soft tissue augmentation surgery with Fibro-Gide; Procedure: Soft tissue augmentation surgery with CTG

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Calciolari, PhD; Phone Number: +44(0)207 882 3134; Email: elena.calciolari@nhs.net
• Study Contact Backup: Name: Vandana Luthra, Dr.; Phone Number: +44(0)207 882 6348; Email: BHNT.Clinicaloralresearchcentre@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2AD
    • Recruiting
    • Barts and The London Dental Hospital
    • Contact: Archana Archana, MSc; Phone Number: 6064 0207 882 6064; Email: BHNT.Clinicaloralresearchcentre@nhs.net
    • Contact: Rinat Ezra, PhD; Phone Number: 6348 0207 882 6348; Email: BHNT.Clinicaloralresearchcentre@nhs.net
  • London, United Kingdom, E1 2AD
    • Recruiting
    • Centre for Oral Clinical Research (COCR)
    • Contact: Rinat Erza, PhD; Phone Number: 0207 882 6348; Email: r.ezra@qmul.ac.uk
    • Contact: Nikolaos Gkranias, DDS, PhD; Phone Number: 0207 882 6348; Email: n.gkranias@qmul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No Soft tissue augmentation surgery; No soft tissue augmentation concomitant to implant placement. Negative control group.	Procedure: No soft tissue augmentation; During implant placement surgery, no soft tissue augmentation will be performed
Experimental: Soft tissue augmentation surgery with Fibro-Gide; Soft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland). Test group.	Procedure: 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.
Active Comparator: Soft tissue augmentation surgery with patient's CTG; Soft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area. Positive control group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
soft tissue aesthetics	Papilla Fill Index and Pink Aesthetic Score	At implant loading and at 12 months after loading.
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
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Collaborators: Geistlich Pharma AG
• Investigators: Principal Investigator: Nikos Donos, PhD, Barts & The London School of Medicine & Dentistry, QMUL

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Estimated): April 3, 2024
• Study Completion (Estimated): September 3, 2024

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: imaging; dental implant; soft tissue regeneration; soft tissue graft
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss; Stomatognathic Diseases
• Other Study ID Numbers: IRAS 268553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No