CTRI Number |
CTRI/2023/08/056629 [Registered on: 18/08/2023] Trial Registered Prospectively |
Last Modified On: |
18/12/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
comparison of bone fill in bony defect around tooth using self blood product vs without any material |
Scientific Title of Study
|
Clinical and radiographic outcomes of the modified minimally invasive surgical technique with or without platelet rich fibrin for the treatment of intrabony defects : a randomized clinical trial |
Trial Acronym |
M-MIST technique with or without PRF for intrabony defects treatment |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Peri srivani |
Designation |
post graduate student |
Affiliation |
SCB Dental College and Hospital |
Address |
Dept of periodontics
SCB dental college and Hospital
mangalabag
Cuttack
Cuttack ORISSA 753007 India |
Phone |
8763516008 |
Fax |
|
Email |
peri.srivani.96@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Neelima Kaatti |
Designation |
Assistant Professor |
Affiliation |
SCB Dental College and Hospital |
Address |
Dept of periodontics
SCB dental college and Hospital
mangalabag
Cuttack
Cuttack ORISSA 753007 India |
Phone |
9337613446 |
Fax |
|
Email |
kattineelima@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Peri srivani |
Designation |
post graduate student |
Affiliation |
SCB Dental College and Hospital |
Address |
Dept of periodontics
SCB dental college and Hospital
mangalabag
Cuttack
Cuttack ORISSA 753007 India |
Phone |
8763516008 |
Fax |
|
Email |
peri.srivani.96@gmail.com |
|
Source of Monetary or Material Support
|
SCB Dental College and Hospital, Mangalabag, Cuttack-753007, Cuttack, Odisha |
|
Primary Sponsor
|
Name |
not applicable |
Address |
not applicable |
Type of Sponsor |
Other [not applicable] |
|
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 |
Peri Srivani |
SCB Dental College and Hospital |
3rd floor, Dept of Periodontics, SCBDCH
Mangalabag
cuttack Cuttack ORISSA |
8763516008
peri.srivani.96@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE, SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
M-MIST technique with PRF |
PRF is considered a second-generation platelet concentrate; it has trimolecular fibrin morphology with a 74% composition of leukocytes, and is known to have osteoconductive, immunomodulatory, and neo-angiogenic properties. In vitro studies have demonstrated that PRF acts as a scaffold for the culture of human periosteal cells and can be applied in bone tissue engineering. Furthermore, it releases autogenous growth factors gradually and manifests a stronger effect on the proliferation and differentiation of osteoblasts.Clinical studies have also demonstrated convincing results of PRF in achieving periodontal regeneration in intrabony defects.
It will take around 6 months for visualising the effects of PRF |
Comparator Agent |
only M-MIST surgical technique |
None |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
1)25 years of age or older.
2)Stage II or III Periodontitis
3)Presence of at least a single site with PPD and clinical attachment level (CAL) ≥5 mm on the buccal surface associated with a 3-walled osseous defect depth of ≥3 mm bilaterally or in both maxillary and mandibular arches.
4)Adequate width of attached gingiva,
5)Plaque index < 30 %
|
|
ExclusionCriteria |
Details |
1)Previous periodontal surgery within the last 6 months in area of interest.
2)Systemic conditions which are generally considered to be a contraindication to periodontal surgery.
3)Pregnant or lactating females
4)Current or former smokers.
5)Hopeless tooth.
6) Patients on systemic medications such as corticosteroids or Calcium channel blockers or taking long-term NSAIDS or taking bisphosphonates or calcium supplements.
7)patients who had periodontal sites with fractured and perforated roots
8) teeth with grade III mobility and furcation involvement
9) non-vital tooth with or without periapical pathology
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
change in clinical attachment level and radiographic Defect depth reduction % from baseline to 6 months postoperative |
baseline to 6 months postoperative |
|
Secondary Outcome
|
Outcome |
TimePoints |
Probing pocket depth
plaque index
modified sulcular bleeding index
Early wound healing score
patient VAS |
0,3 month, 6 month |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
28/08/2023 |
Date of Study Completion (India) |
15/11/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
15/11/2024 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [peri.srivani.96@gmail.com].
- For how long will this data be available start date provided 31-12-2022 and end date provided 28-09-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Periodontitis
results in increased pocket depth, intrabony defects, gingival recession, tooth
mobility, furcation involvement. Intrabony defect
is defined as periodontal defect surrounded by one, two or three bony walls or
a combination of thereof. Various
regenerative materials are incorporated into the intrabony defects by open flap
debridement and guided tissue regeneration. In conventional
surgical approach ,large flaps are raised to completely and exceedingly expose
the area of interest and the results were unsatisfactory due to limited
regenerated periodontal tissue. Thus, an alternative approach to access the
intra-bony defects was proposed. This approach is called minimally invasive
surgical techniques which uses incisions just large enough for debridement and
generally involves reflecting the papilla only by using specialized instruments
to access the intra-bony defect.
The introduction
of operative microscopes and microsurgical instruments resulted in increased
surgical effectiveness by improving the visual acuity & accuracy and better
control of the surgical instruments resulting in reduced flap reflection. Following the
principles of papilla preservation flap, Cortellini and Tonetti
recommended the use of the minimally invasive surgical technique (MIST) with
microsurgical instruments and operating microscope that demonstrated better
healing in terms of significant gain in
attachment level, pocket depth reduction, and minimal gingival recession in the
treatment of isolated deep intrabony defects.
The Modified-MIST
(M-MIST) was introduced by Cortellini & Tonnetti to reduce surgical
invasiveness by limiting the incision line to the buccal side. This fulfilled
the following objectives: (i) to maintain the interdental papillary height by
minimizing its tendency to collapse; (ii) to increase the likelihood of primary
wound closure; (iii) to reduce the chances of gingival recession; (iv) to
improve flap stability; (v) to maintain space for regeneration; (vi) reduce
patient morbidity (vii) better ergonomics.
Various randomised
controlled clinical trials have been conducted to study the efficacy of M-MIST
in the treatment of intrabony defects with and without regenerative materials
such as enamel matrix derivative (EMD), bone mineral derived xenograft (BMDX),
and recombinant human platelet derived growth factor (rhPDGF). Very few clinical
trials have been attempted to study the use of M-MIST with autologous
platelet-rich-fibrin (PRF).
PRF is considered
a second-generation platelet concentrate; it has trimolecular fibrin morphology
with a 74% composition of leukocytes, and is known to have osteoconductive,
immunomodulatory, and neo-angiogenic properties. In vitro studies
have demonstrated that PRF acts as a scaffold for the culture of human
periosteal cells and can be applied in bone tissue engineering. Furthermore, it
releases autogenous growth factors gradually and manifests a stronger effect on
the proliferation and differentiation of osteoblasts. Clinical studies
have also demonstrated convincing results of PRF in achieving periodontal
regeneration in intrabony defects, class II furcation defects, coronally
advanced flaps with multiple gingival recession, and sinus augmentation during
implant placement.
Considering the
benefits of PRF for augmenting bone and soft tissue healing, it is hypothesized
that PRF could act as an adjunct to M-MIST, potentially yielding better results
than M-MIST alone in the treatment of isolated intrabony defects. Thus, the aim
of this study is to observe the outcomes of periodontal surgery in which M-MIST
is used with or without PRF for the treatment of isolated intrabony defects. |