| CTRI Number |
CTRI/2020/06/025950 [Registered on: 17/06/2020] Trial Registered Prospectively |
| Last Modified On: |
10/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relative assessment of gum preservation using two surgical techniques for treatment of bone defects |
|
Scientific Title of Study
|
Comparative Evaluation of Soft Tissue Preservation Using Non
Incised Papilla Surgical Approach and Papilla Preservation
Technique for Treatment of Intrabony Defects: A Randomized
Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yugandhara Rameshsingh Desurkar |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
202, Periodontology pg clinic, second floor, Govt Dental College and Hospital, Opposite MARD canteene, medical campus, Hanuman Nagar, Nagpur-440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9657997558 |
| Fax |
|
| Email |
yugandharadesurkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Karemore |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
212, Dept of Periodontology , second floor, Govt Dental College and Hospital, Opposite MARD canteene, medical campus, Hanuman Nagar, Nagpur-440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9011098882 |
| Fax |
|
| Email |
drperiodon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yugandhara Rameshsingh Desurkar |
| Designation |
Postgraduate student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
202, Periodontology pg clinic, second floor, Govt Dental College and Hospital, Opposite MARD canteene, medical campus, Hanuman Nagar, Nagpur-440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9657997558 |
| Fax |
|
| Email |
yugandharadesurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontology,Government Dental College and Hospital, Opposite MARD canteene, Medical campus, Nagpur-440003 |
|
|
Primary Sponsor
|
| Name |
Dept of periodontology |
| Address |
Govt Dental College and Hospital, opposite MARD canteene, Medical campus, Nagpur-440003 |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 Yugandhara Rameshsingh Desurkar |
Government Dental College and Hospital Nagpur |
202, Periodontology PG clinic, Second floor, Government Dental College and Hospital,opposite MARD canteene, Medical Campus, Nagpur- 440003
Nagpur
MAHARASHTRA |
9657997558
yugandharadesurkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non Incised Papilla Surgical Approach (NIPSA) Technique |
Moreno RodrÃguez et al in 2017 introduced NIPSA technique.
It is a variant of papilla preservation technique. In this technique an
apical approach will be carried out. No incisions will be given at
papilla or marginal tissues. In this technique incision will be located
intrasulcularly at the level of the marginal tissue and in the area of
the papillae, with the subsequent disinsertion of these tissues for the treatment of the periodontal defect.
NIPSA facilitate the treatment of deep intrabony defects,
associated with high risk of soft tissue collapse and postsurgery soft tissues shrinkage. |
| Comparator Agent |
Papilla Preservation Technique |
In order to preserve the
interdental soft tissues for maximum soft tissue coverage following
surgical intervention involving treatment of proximal osseous defects, Takei et al. (1985) proposed a surgical approach called papilla preservation technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with localized chronic periodontitis
2) Periodontal lesions with probing pocket
depth (PPD) > 5 mm
3) Periodontal pockets with CAL> 5mm
4) Intrabony defect > 3 mm |
|
| ExclusionCriteria |
| Details |
1) Patients with systemic diseases that contraindicated
treatment and under medication that alter wound healing.
2Teeth with incorrect endodontic or restorative Treatment.
3)Patients on anticoagulants and/or with blood diseases. 4)Pregnant or lactating mother and smokers
5)Patients with malocclusion and undergoing orthodontic treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Clinical attachment level gain
2)Tip of the papilla
3)Pocket probing depth |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival recession height |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intrabony defect is defined by the apical location of the base of the pocket with respect to residual alveolar ridge affecting primarily one tooth. Classification of intrabony defects based on presence of bony walls is, one wall, two wall and three wall defects. There are different surgical approaches for reconstructive treatment of intrabony defects like papilla preservation technique, modified papilla preservation technique, entire papilla preservation technique, minimally invasive surgical technique(MIST), Modified Vestibular Incision Subperiosteal Tunnel Approach(M-VISTA) and Non Incised Papilla Surgical Approach(NIPSA). Papilla Preservation Technique: In order to preserve the interdental soft tissues for maximum soft tissue coverage following surgical intervention involving treatment of proximal osseous defects, Takei et al. (1985)[5] proposed a surgical approach called papilla preservation technique. Non Incised Papilla Surgical Approach(NIPSA): - Moreno RodrÃguez et al in 2017 introduced NIPSA technique.It is a variant of papilla preservation technique. In this technique an apical approach will be carried out. No incisions will be given at papilla or marginal tissues. In this technique incision will be located intrasulcularly at the level of the marginal tissue and in the area of the papillae, with the subsequent disinsertion of these tissues for the treatment of the periodontal defect. NIPSA facilitate the treatment of deep intrabony defects, associated with high risk of soft tissue collapse and postsurgery soft tissues shrinkage. Graft material for regenerative procedure: Ideal graft material for regenerative procedure is autogenous bone graft, but major disadvantage is need for second surgical site and frequent lack of intraoral donor site for sufficient quantities of autogenous bone. So, bone allografts were developed to overcome this disadvantage. Demineralized Freeze Dried Bone Allograft (DFDBA) provides an osteoinductive scaffold due to presence of bone morphogenic proteins and elicits resorption when implanted in mesenchymal tissues. Both Papilla Preservation Technique and Non Incised Papilla Surgical Approach are mainly soft tissue preservation technique. There is scarcity in literature with intergroup comparison studies between both techniques so this study is planned. |