| CTRI Number |
CTRI/2025/03/082387 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION OF NON-INCISED PAPILLAE SURGICAL APPROACH (NIPSA) FOR INTRABONY DEFECTS UTILIZING BONE GRAFT SUBSTITUTES |
|
Scientific Title of Study
|
EVALUATION OF NON-INCISED PAPILLAE SURGICAL APPROACH (NIPSA) FOR INTRABONY DEFECTS UTILIZING ADVANCED-PLATELET RICH FIBRIN BLOCK: A CLINICO-RADIOGRAPHIC STUDY. |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raksha Kumari |
| Designation |
Post graduate Student |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room No 05, Department of Periodontics, Bapuji Dental College and Hospital,MCC B block, Davangere,
Davanagere
KARNATAKA
577004
India |
| Phone |
8277361062 |
| Fax |
|
| Email |
prabhuraksha1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Triveni MG |
| Designation |
Professor & Head |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room No 05, Department of Periodontics, Bapuji Dental College and Hospital,MCC B block, Davangere,
Davanagere
KARNATAKA
577004
India |
| Phone |
9449019711 |
| Fax |
|
| Email |
2012mgtriveni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raksha Kumari |
| Designation |
Post graduate Student |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room No 05, Department of Periodontics, Bapuji Dental College and Hospital,MCC B block, Davangere,
Davanagere
KARNATAKA
577004
India |
| Phone |
8277361062 |
| Fax |
|
| Email |
prabhuraksha1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics, Bapui Dental College and Hospital, MCC B Block, Davangere, Karnataka, India-577004 |
|
|
Primary Sponsor
|
| Name |
Dr Raksha Kumari self |
| Address |
Room No. 05, Department of Periodontics, Bapuji Dental college and Hospital, MCC B Block, Davangere, Karnataka, India-577004 |
| Type of Sponsor |
Other [self] |
|
|
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 Raksha Kumari |
Bapuji Dental College and Hospital |
Room No 05, Department of Periodontics, Bapuji Dental College and Hospital,MCC B block, Davangere,
Davanagere
KARNATAKA |
8277361062
prabhuraksha1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Review Board, Bapuji Dental College and Hospital, Davangere |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-Incised Papillae Surgical Approach (NIPSA) |
All patients will be operated under local anaesthesia(2% Lignocaine with 1:800,000 adrenaline), which will be administered either by nerve block or infiltration. To access the defect, a single horizontal incision will be placed in the mucosa delimiting the defect as per CBCT observation. The tissue coronal to the incision will be raised full thickness maintaining the papillae architecture intact. Debridement will be done usuing mini-five curettes. After thorough debridement, 24% EDTA will be applied to the root surface. After 2 minutes, saline irrigation will be done followed by filling the defect with A-PRF Block. Then the incision line will be sutured (5-0 Trulene) first with internal horizontal mattress suture and the second with the single interrupted sutures. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Defects confined to anterior & premolars and periodontal probing depth greater than or equal to six millimeter.
2.Intrabony defects configuration including one and/or two-wall components, always involving buccal wall.
3. Intrabony defect depth greater than or equal to three millimeter..
4. all patients available for follow up |
|
| ExclusionCriteria |
| Details |
1. Patients on drug therapy (like bisphosphonates, antiplatelet, anticoagulants, immunosuppressants)which can affect the outcome.
2. Patients with habit of smoking, alcohol or tobacco chewing.
3. Pregnancy or lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Probing depth(PD)
2. Clinical Attachment level (CAL)
3. Defect fill using CBCT
4. Bone density at the centre of the defect |
1. at baseline
2. six month post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. gingival thickness analysis at the centre of the defect |
at baseline and six month post operative |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
27/03/2025 |
| 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="1"
Months="0"
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
|
The current single arm study was designed to treat intrabony defects with Non-Incised Papillae Surgical Approach(NIPSA). The research hypothesis of the study is there is a change in change in pre and post treatment clinical and radiographic outcomes with the defect was treated with NIPSA technique along with A-PRF Black. All the patients will be undertaken for the study after the consent is obtained from the patients. All patients will be operated under local anaesthesia with a solution of 2% lignocaine with 1:80,000 adrenaline. Anaesthesia will be administered by either nerve block or local filtration. After anaesthesia, transgingival probing will be done and intrabony defect measurements will be recorded using UNC-15 probe before the incision is placed. To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesio-distally as necessary to allow access to the defect. The tissue coronal to the incision will be raised full thickness, to maintain the pre-operative marginal tissue and the papillae architecture intact. The granulation tissue will be removed from the adjacent osseous walls by mini- five curettes. If the defect presented a lingual component, the lingual area will be instrumented through the vestibular access. The affected root (deep area of the periodontal pocket) will be scaled and planed, and calculus will be eliminated. After defect debridement and instrumentation of the root surface, 24% ethylenediaminetetraacetic acid (EDTA) will be applied to the root surface. After 2 minutes, saline irrigation will be done followed by filling of the intraosseous defect with A-PRF block. Then the incision line will be sutured (5-0, Trulene) by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. Patients will be recalled after 14-days for suture removal and 6 months post operatively for the evaluation of the treatment outcomes. |