| CTRI Number |
CTRI/2024/05/067607 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Tissue Changes Around Dental Implants with a collagen membrane versus Connective Tissue Grafts in patients with thin gingival conditions. |
|
Scientific Title of Study
|
Comparison of Soft and Hard Tissue Changes Around Dental Implants with Xenogenic Collagen and Connective Tissue Grafts Using Intraoral Scanner and Radiographs: Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sejal Satish Mali |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department no.202,Second floor, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur, 440003.
Nagpur MAHARASHTRA 440003 India |
| Phone |
9518795547 |
| Fax |
|
| Email |
sejalmali1998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vaibhav Karemore |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department no.202,Second floor, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur, 440003.
Nagpur MAHARASHTRA 440003 India |
| Phone |
9011098882 |
| Fax |
|
| Email |
drperiodon@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vaibhav Karemore |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department no.202,Second floor, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur, 440003.
MAHARASHTRA 440003 India |
| Phone |
9011098882 |
| Fax |
|
| Email |
drperiodon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, Hanuman Nagar, Medical square, Nagpur-440003 |
|
|
Primary Sponsor
|
| Name |
Dr. Sejal Satish Mali |
| Address |
Department no. 202, department of periodontology, second floor,
Government dental college and hospital , Medical square, Hanuman
Nagar, Nagpur-440003
|
| Type of Sponsor |
Other [Self sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sejal Satish Mali |
Government dental college and hospital, Nagpur |
Department no.202,
department of
periodontology,
Government dental
college and hospital,
Medical square,
Hanuman Nagar,
Nagpur Nagpur MAHARASHTRA |
9518795547
sejalmali1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government Dental College and hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Connective tissue graft |
A connective tissue graft will be placed around dental implants at the time of stage II implant surgery. Soft tissue thickness, surface area around implants and crestal bone loss will be assessed after 90 days. |
| Intervention |
Xenogenic collagen scaffold |
A Xenogenic collagen scaffold will be placed around dental implants at the time of stage II implant surgery. Soft tissue thickness, surface area around implants and crestal bone loss will be assessed after 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with age of 18-60 years.
2)Patient who had undergone dental implant stage I surgery.
3)Patient with thin gingival phenotype.
4)Adequate oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1)Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
2)Patients with thick gingival phenotype around implants.
3)Patients with implant sites that presented complications.
4)Patients who are not willing for the xenogenic graft which is
of porcine origin.
5)Pregnant or lactating females.
6)Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of soft tissue thickness and surface area around implants. |
Evaluation of soft tissue thickness will be done at baseline and after 90 days and surface area around implants will be evaluated after 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Crestal bone loss |
Crestal bone loss will be evaluated at baseline & 90 days after stage II implant surgery.
|
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| Implant dentistry has become an integral part of modern dentistry and its success is no longer determined merely by osseointegration.There is a paradigm shift in dental implantology with an increased importance placed on the quality and quantity of soft tissues around dental implants to improve the surgical, esthetic and prosthetic outcomes of the implant therapy.
|
Albrektsson
recently coined this as a new concept
called ‘mucointegration’ which means dense soft tissue contact with an
abutment that can act as a barrier to protect the underlying bone and is the
basis for long term tissue health and stability. Long
term peri-implant soft tissue stability is affected by the peri-implant tissue
phenotype. The term encompasses the three-dimensional gingival volume and
thickness. Thin phenotype predisposes the tissues to
attachment loss. They are at a higher risk of esthetic complications in the
long term like mid-facial peri-implant mucosal recession, incomplete papilla
fill and decreased soft tissue stability which may lead to implant failure. Crestal
bone loss has been linked to thinner gingival phenotypes as the thick gingival
phenotypes are less prone to buccal changes. Adequate amount of soft tissue is
needed to curb the crestal bone loss & achieve biologic width of the peri-implant mucosa. Various
methods have been proposed for obtaining adequate amounts of gingival soft
tissue thickness depending on the technique and patients need. These can be
performed before implant placement, at the time of implant placement or at the
time of second stage implant surgery. Apically positioned flaps, laterally
positioned flaps, free gingival grafts or connective tissue grafts are some of
the most commonly used methods for increasing the zone of soft tissue thickness around implants. Current
scientific data recommends the use of autogenous connective tissue grafts (CTG) as the
grafting material of choice for increasing the soft tissue thickness and
improving the esthetics around dental implant sites. But the CTG is inevitably
accompanied by increased morbidity as it requires an additional harvesting
procedure. To overcome the drawbacks of the autogenous
grafts many alternative materials such as xenogenic collagen scaffold have been developed. The fundamental issue is to choose the material
which will assure the maximum therapeutic effect while minimizing the negative
influence on the patient’s health. The collagen matrix offers mechanical stability associated with good biological behaviour, promotes tissue formmation, angiogenesis & similar outvomes compared to gold standard in terms of volume increase. Periodontal
probes and endodontic files are commonly used to evaluate soft tissue changes.
But these evaluate the changes only
in one-dimension. At present, digital methods for evaluating peri-implant soft
tissue changes have gradually become an outcome of interest in different
literatures possibly because of its noninvasiveness, accuracy, and the digital
information could be saved in computer permanently. A recent study summarized
the available evidence regarding traditional and digital methods for the
evaluation of peri-implant soft tissue changes and concluded that traditional
methods can’t show the entire changes while digital methods can. The
digital scanned files obtained by an intraoral scanner can be converted into
Standard Tessellation Language (STL) file formats. These
files are transferred to a three dimensional analysis software where they are
superimposed and evaluation of the change in thickness can be done. There
are limited studies involving the use of digital methods for the evaluation of
peri-implant soft tissue changes. Thus the aim of the study is to compare the
soft and hard tissue changes around dental implants at stage II implant surgery
with xenogenic collagen scaffold and connective tissue graft using intraoral
digital scanner and radiographs.
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