search
Back to results

Soft Tissue Changes Around Dental Implants (Geistlich)

Primary Purpose

Tooth Loss, Dental Diseases, Wound Heal

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Soft tissue augmentation surgery with CTG
Soft tissue augmentation surgery with Fibro-Gide
No soft tissue augmentation
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring soft tissue regeneration, soft tissue graft, dental implant, imaging

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Barts and The London Dental HospitalRecruiting
  • Centre for Oral Clinical Research (COCR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

No Soft tissue augmentation surgery

Soft tissue augmentation surgery with Fibro-Gide

Soft tissue augmentation surgery with patient's CTG

Arm Description

No soft tissue augmentation concomitant to implant placement. Negative control group.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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
3D extra-oral volumetric changes
3D extra-oral morphometric changes assessed with a facial scanner
2D-3D intra-oral thermal changes
2D-3D intra-oral thermal changes using an infrared, contact-free, thermal camera
changes in vascularisation
Changes in revascularization in the area of the implant surgery with laser speckle contrast imaging
soft tissue aesthetics
Papilla Fill Index and Pink Aesthetic Score
changes in height of keratinised tissue
changes in height of keratinised tissue measured with a probe
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.
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
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.
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).

Full Information

First Posted
January 23, 2020
Last Updated
May 26, 2023
Sponsor
Queen Mary University of London
Collaborators
Geistlich Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT04265768
Brief Title
Soft Tissue Changes Around Dental Implants
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
April 3, 2024 (Anticipated)
Study Completion Date
September 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
Geistlich Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss, Dental Diseases, Wound Heal
Keywords
soft tissue regeneration, soft tissue graft, dental implant, imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will includes 3 groups randomised in parallel.
Masking
Outcomes Assessor
Masking Description
Due to the nature of the intervention, both participants and clinicians performing the surgical intervention will be un-blinded. Conversely, outcome examiners will be blinded to treatment allocation throughout the whole study duration.
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Soft tissue augmentation surgery
Arm Type
Placebo Comparator
Arm Description
No soft tissue augmentation concomitant to implant placement. Negative control group.
Arm Title
Soft tissue augmentation surgery with Fibro-Gide
Arm Type
Experimental
Arm Description
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.
Arm Title
Soft tissue augmentation surgery with patient's CTG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Soft tissue augmentation surgery with CTG
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Soft tissue augmentation surgery with Fibro-Gide
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No soft tissue augmentation
Intervention Description
During implant placement surgery, no soft tissue augmentation will be performed
Primary Outcome Measure Information:
Title
3D intra-oral volume changes in mucosal soft tissue following augmentation
Description
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Time Frame
Immediately after implant placement.
Title
3D intra-oral volume changes in mucosal soft tissue following augmentation
Description
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Time Frame
7, 14 and 30 Days post implant placement
Title
3D intra-oral volume changes in mucosal soft tissue following augmentation
Description
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Time Frame
12 weeks and 16 weeks post- implant loading.
Title
3D intra-oral volume changes in mucosal soft tissue following augmentation
Description
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Time Frame
12 month post- implant loading.
Secondary Outcome Measure Information:
Title
Changes in gingival thickness
Description
Changes in gingival thickness from the time of implant placement (with or without graft) and 12 weeks after implant placement assessed by a caliper
Time Frame
implant placement to 12 weeks after implant placement
Title
3D extra-oral volumetric changes
Description
3D extra-oral morphometric changes assessed with a facial scanner
Time Frame
baseline, immediately after implant placement, 7, 14 and 30 days after implant placement
Title
2D-3D intra-oral thermal changes
Description
2D-3D intra-oral thermal changes using an infrared, contact-free, thermal camera
Time Frame
baseline to 1, 3, 7, 14 and 30 days after implant placement
Title
changes in vascularisation
Description
Changes in revascularization in the area of the implant surgery with laser speckle contrast imaging
Time Frame
before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30
Title
soft tissue aesthetics
Description
Papilla Fill Index and Pink Aesthetic Score
Time Frame
At implant loading and at 12 months after loading.
Title
changes in height of keratinised tissue
Description
changes in height of keratinised tissue measured with a probe
Time Frame
baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading
Title
Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP)
Description
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.
Time Frame
At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Title
PROMs based on the evaluation of global changes in quality of life
Description
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
Time Frame
At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Title
PROMs based on the evaluation of patient's perception about therapy
Description
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.
Time Frame
At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Title
Post-operative swelling and oedema
Description
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).
Time Frame
At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Calciolari, PhD
Phone
+44(0)207 882 3134
Email
elena.calciolari@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Vandana Luthra, Dr.
Phone
+44(0)207 882 6348
Email
BHNT.Clinicaloralresearchcentre@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikos Donos, PhD
Organizational Affiliation
Barts & The London School of Medicine & Dentistry, QMUL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts and The London Dental Hospital
City
London
ZIP/Postal Code
E1 2AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinat Ezra, PhD
Phone
0207 882 6348
Ext
6348
Email
BHNT.Clinicaloralresearchcentre@nhs.net
First Name & Middle Initial & Last Name & Degree
Archana Archana, MSc
Phone
0207 882 6064
Ext
6064
Email
BHNT.Clinicaloralresearchcentre@nhs.net
Facility Name
Centre for Oral Clinical Research (COCR)
City
London
ZIP/Postal Code
E1 2AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinat Erza, PhD
Phone
0207 882 6348
Email
r.ezra@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Nikolaos Gkranias, DDS, PhD
Phone
0207 882 6348
Email
n.gkranias@qmul.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Soft Tissue Changes Around Dental Implants

We'll reach out to this number within 24 hrs