| CTRI Number |
CTRI/2024/09/073429 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the clinical outcomes of minimally invasive surgical procedures; minimally invasive surgical technique (MIST) and modified minimally invasive technique (M-MIST). |
|
Scientific Title of Study
|
COMPARISION OF CLINICAL EFFICACY OF MINIMALLY INVASIVE SURGICAL TECHNIQUE (MIST) VERSUS MODIFIED- MINIMALLY INVASIVE SURGICAL TECHNIQUE (M-MIST) IN THE TREATMENT OF PERIODONTAL INFRABONY DEFECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syeda Sumayya Mazhar |
| Designation |
Junior Resident |
| Affiliation |
Department of Periodontia and community dentistry |
| Address |
Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh Aligarh UTTAR PRADESH 202002 India |
| Phone |
9634538950 |
| Fax |
|
| Email |
syedasumayya01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
ND Gupta |
| Designation |
Professor |
| Affiliation |
Department of Periodontia and community dentistry |
| Address |
Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh Aligarh UTTAR PRADESH 202002 India |
| Phone |
9412817009 |
| Fax |
|
| Email |
ndguptaligarh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Saif Khan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Periodontia and community dentistry |
| Address |
Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh Aligarh UTTAR PRADESH 202002 India |
| Phone |
9012875280 |
| Fax |
|
| Email |
skhan.pu@amu.ac.in |
|
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Source of Monetary or Material Support
|
| Department of Periodontia and community dentistry, Dr. Ziauddin Ahmad dental college A.M.U. Aligarh 202002, Uttar Pradesh, India. |
|
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Primary Sponsor
|
| Name |
Department of Periodontia and Community dentistry |
| Address |
Dr. Ziauddin Ahmad dental college A.M.U. Aligarh |
| Type of Sponsor |
Other [Government dental college] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Syeda Sumayya Mazhar |
Dr Ziauddin Ahmad Dental College and Hospital |
Department of Periodontia and community dentistry A.M.U. Aligarh UTTAR PRADESH |
9634538950
syedasumayya01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Minimally invasive surgical technique (MIST) with i-PRF. |
MIST is based on the elevation of the defect associated interdental papilla along with minimally extended buccal and lingual flap; with use of injectable platelet-rich fibrin (i-PRF). |
| Intervention |
Modified Minimally invasive surgical technique(M-MIST) with i-PRF. |
M-MIST is based on the elevation of only buccal flap, which enhances the concept of MIST by avoiding the interdental papilla as well as palatal flap dissection and elevation; with the use of injectable platelet-rich fibrin (i-PRF). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
periodontitis (stage III-IV)
Systematically healthy patient
Contained infrabony defects |
|
| ExclusionCriteria |
| Details |
Patients who had received periodontal treatment within the previous three months.
Pregnant or lactating
Third molars
Teeth with grade III mobility |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical outcomes in terms of pocket probing depth (PPD) reduction, clinical attachment level (CAL) gain and bone fill (BF) in the treatment of periodontal infrabony defects. |
Final clinical and radiographic outcomes will be evaluated at 6 months follow-up. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the early healing index of periodontal soft tissue wounds after the surgery.
2. To quantify radiographically, regeneration of interdental bone using CBCT.
3. To compare the clinical, radiological and patient centered outcomes of minimally invasive surgical technique (MIST) with the modified minimally invasive surgical technique (M-MIST). |
Subjects will be recalled after 7 days for evaluation of early wound healing index; at 3 months for soft tissue evaluation, and then the final clinical and radiographic outcomes will be evaluated at 6 months follow-up. |
|
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Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Minimally invasive surgery (MIS)/ minimal access surgery (MAS) was introduced with the aim to produce minimal wounds, minimal flap reflection and gentle handling of the soft tissues. Minimally invasive surgical technique (MIST) is based on the elevation of the defect-associated interdental papilla along with minimally extended buccal and lingual flaps. The Modified-MIST is based on elevation of only buccal flap, further enhances the concept of MIST by avoiding the interdental papilla as well as palatal flap dissection and elevation. Minimally invasive surgical technique (MIST) focuses on wound and blood clot stability and primary wound closure for clot protection. This regeneration is possible with reduced patient morbidity, and unaesthetic results are minimized or eliminated. Modified minimally invasive surgical technique (M-MIST) incorporated the concept of space provision for regeneration. In the field of regeneration, there are barrier membranes, grafts, and wound healing modifiers alone or in combinations. Noteworthily, dimensional changes of alveolar bone following tooth loss have remained a prominent challenge for the clinician and a variety of regenerative procedures have since been utilized. One such proposed method has been the use of platelet concentrates, platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (iPRF) which both uses supra-physiological doses of autologous growth factors derived from the patient’s own blood further capable of speeding tissue regeneration. A major problem to overcome applying minimally invasive surgery is the problem of visibility and manipulation of surgical field. High magnification and direct optical illumination provided by a surgical microscope or loupes can be of great help. Also, soft tissue manipulation during instrumentation requires special care. Small instruments like small periosteal elevators, tiny forceps, mini curette are mandatory for gentle manipulation of hard and soft tissues. |