| CTRI Number |
CTRI/2025/03/081649 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate the use of injectable platelet rich fibrin for increasing soft tissue around dental implants |
|
Scientific Title of Study
|
In-vitro & biomarker based clinical evaluation of I-PRF in soft tissue augmentation around dental implants - A single blinded 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 P Harinath |
| Designation |
Professor |
| Affiliation |
SRM Dental College |
| Address |
Department of Periodontology,SRM Dental College,Bharathi salai, Ramapuram, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9840482400 |
| Fax |
|
| Email |
harinatp@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirmala Anandan |
| Designation |
Professor and Head of the department of Biochemistry |
| Affiliation |
SRM Dental College |
| Address |
Department of Biochemistry, SRM Dental College,Bharathi
salai,Ramapuram,Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9444280636 |
| Fax |
|
| Email |
dr_s_nirmala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmala Anandan |
| Designation |
Professor and Head of the department of Biochemistry |
| Affiliation |
SRM Dental College |
| Address |
Department of Biochemistry, SRM Dental College,Bharathi
salai,Ramapuram,Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9444280636 |
| Fax |
|
| Email |
dr_s_nirmala@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College,Bharathi salai,Ramapuram,Chennai. Chennai TAMIL NADU 600089 India |
|
|
Primary Sponsor
|
| Name |
Dr P Harinath |
| Address |
Department of Periodontology, SRM Dental College,Bharathi salai,Ramapuram,Chennai.
Chennai
TAMIL NADU
600089
India |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM Dental College |
Third floor, Department of Periodontology, SRM Dental College, Ramapuram, Chennai 600089
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Harinath |
SRM Dental College |
SRM Dental
College,Department of
Periodontology, 3rd
Floor, Bharathi salai,Ramapuram,Chennai.
Chennai
TAMIL NADU |
9840482400
harinatp@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Dental College, Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
With Collagen and i-PRF |
33 implant sites treated with
i-PRF infused collagen matrix
during implant placement and evaluating the change in soft tissue width will be measured at 0,3 and 6 months |
| Comparator Agent |
Without Collagen and i-PRF |
33 implant sites treated without any biomaterial during implant placement and evaluating the change in soft tissue width will be measured at 0,3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients within the age range of 30-60 years.
2.Patients with thin soft tissue biotype.
3.Patient with single isolated edentulous sites requiring implant placement |
|
| ExclusionCriteria |
| Details |
1.Patients requiring regeneration at the edentulous site.
2.Smoking(more than 10 cigs/day).
3. Pregnant and lactating women.
4. Patients showing unacceptable oral hygiene compliance during/after phase I therapy.
5. Systemic condition / disease/ any medication having influence on course of therapy
6. Patients with relative/absolute contraindication for implant placement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate changes in the buccal soft tissue thickness |
Subject will be evaluated at 0,3 and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in the width of the keratinized tissue
2.changes in the height in the gingival margin
3.Radiographic changes in the crestal bone
4.changes in the thickness of buccal bone
5.bleeding on probing |
Subject will be evaluated at 0,3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Dental implant treatment is a successful, widespread and predictable
treatment for tooth loss over the past 20 years however, an increasing
number of implant failures caused by peri-implant diseases are evident in
clinical dental practice. Two forms of peri-implant inflammation have been
identified in the literature: peri-implant mucositis and peri-implantitis.
Peri-implant tissues are divided into soft and hard tissue compartments.
The soft tissue compartment is denoted “peri-implant mucosa” and is
formed during the wound healing process that follows implant and
abutment placement. The hard tissue compartment forms a contact
relationship to the implant surface to secure implant stability. Due to their
histologic and anatomic features, peri-implant tissues carry out two basic functions: the mucosa protects the underlining bone, while the bone
supports the implant. Emerging evidence suggests that buccal keratinized
tissue (KT) around dental implant may be critical to prevent peri-implant
inflammation and mucosal recession. Furthermore, adequate volume/thick
biotype of peri-implant soft tissue prevents crestal bone resorption that
may otherwise occur with thin peri-implant mucosa . Therefore, the careful
management of soft tissue around implants is considered a key factor to
obtain aesthetic outcomes and to support long-term successful
maintenance. The gingival thickness affects the treatment outcome
possibly because of the difference in the amount of blood supply to the
underlying bone and lesser susceptibility to crestal bone resorption.Based
on scientific evidence connective tissue grafts are considered to be the
gold standard for soft tissue augmentation. Major disadvantages and
limitations associated with the use of connective tissue grafts, are the
painful healing at harvested sites and variations in quality and quantity of
tissue that is available for grafting. In order to overcome these drawbacks
and to standardize grafting procedures, soft tissue substitutes have been
introduced. The collagen matrices demonstrates favorable mechanical
and biological properties, enhancing connective tissue formation,
undergoing simultaneous remodeling process and
degradation.Autologous Platelet concentrates (PRP, PRF) have been
used in dentistry for over three decades as a regenerative tool capable of
releasing supraphysiological doses of growth factors responsible for
inducing tissue regeneration. Taking advantage of slower and shorter
centrifugation speeds, a higher presence of regenerative cells with higher
concentrations of growth factors are observed with a newer formulation
namely I-PRF (injectable PRF), has shown to be capable of influencing
cell activity of gingival fibroblasts and inducing higher cell migration. The
well-known positive
properties of I-PRF in the soft
tissue wound-healing cascade makes this an optimal choice when treating
deficient soft tissue at implant sites. Currently, no data are available using
I-PRF in enhacing soft tissue volume around dental implants. Therefore
the aim of the present study is to evaluate I-PRF in augmenting peri
implant soft tissue. |