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Decortication With Calcium Phosphosilicate Putty in the Treatment of Non-contained Intrabony Periodontal Defects

Primary Purpose

Periodontal Bone Loss

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
OFD+IMP+CPS
OFD+IMP
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Bone Loss

Eligibility Criteria

28 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with chronic periodontitis
  • Presence of non- contained osseous defect
  • Age 28 to 60 years (both males and females)
  • Completed etiological periodontal therapy (oral hygiene instructions and scaling and root planing under local anaesthesia.
  • At re-evaluation full mouth plaque score67 < 1, full mouth bleeding score FMBS <20%
  • Non-smokers (Current and past smokers)
  • Presence of ≥ 2mm of keratinized tissue to allow flap management

Tooth defect criteria:

  • Probing pocket depth ≥ 5mm
  • Clinical attachment loss ≥ 5mm
  • Associated with a 1-wall, 2-wall or a combined 1-2 wall osseous defect ≥ 3mm deep located in the interproximal area of single- and multirooted teeth (assessed by transgingival probing and radiograph, further to be confirmed after flap elevation)
  • Tooth mobility ≤ 1
  • Concerned tooth and adjoining teeth to be vital and without symptoms or signs of endodontic involvement
  • Tooth and adjoining teeth free of caries or inadequate restorations/ unrestorable tooth.
  • Absence of non-working interferences.
  • Interproximal intrabony defects not extending into the furcation area of molar teeth.

Exclusion Criteria:

  • Medical conditions interfering with periodontal health or wound healing
  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Pregnant or lactating women.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • History of recent periodontal treatment within 6 months prior to study.
  • 3-wall intrabony defects

Sites / Locations

  • Shikha TewariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group OFD+IMP+CPS

Control group (OFD+IMP)

Arm Description

OFD+IMP+CPS; open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty (CPS)

OFD+IMP;open flap debridement (OFD) and intramarrow penetration (IMP)

Outcomes

Primary Outcome Measures

Bone fill,
bone growth fill in mm
CAL
clinical attachment level gain in mm

Secondary Outcome Measures

Full Information

First Posted
January 30, 2018
Last Updated
February 9, 2018
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT03435757
Brief Title
Decortication With Calcium Phosphosilicate Putty in the Treatment of Non-contained Intrabony Periodontal Defects
Official Title
Surgical Outcomes of Decortication With or Without Calcium Phosphosilicate Putty Following Regenerative Therapy of Non-Contained Intrabony Periodontal Defects: A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To overcome the disadvantage of complex morphology and availability of less favorable support to retention of graft and clot stabilization in 1-, 1-2-wall periodontal defects, it was hypothesized that placement of CPS putty having the property of being easily moldable and shaped along with decortication would provide better healing outcome as compared to decortication alone in 1-, 1-2-wall periodontal defects. Therefore with this rationale, the present study is carried out to evaluate the treatment outcomes of decortication with and without use of CPS putty in 1- wall, 1-2-wall periodontal defects.
Detailed Description
The definite goal of periodontal regenerative therapy is to restore the tooth supporting tissues, lost as a result of inflammatory periodontal diseases and infections. Numerous treatment modalities have been described and tested, including use of non resorbable and resorbable membranes (GTR) ; autogenous bone grafts, bone allografts, xenografts and synthetic materials, and bioactive molecules (EMD) and growth factors. Furthermore researches on cell therapy and gene therapy utilization to boost the reparative potential of the wound tissues are also being carried out. Each of the treatment modalities have their own limitations and advantages. Autogenous bone grafts having good osteogenic and osteoconductive capacity than other grafts are considered to be the best but need for a second surgery, postoperative complaints and insufficient amount of bone graft obtained restrict their use. Allografts and xenografts use is also limited because of their controversial osteoinduction capability, ethical problems, infections and immunological rejection risk. As a result of the varying disadvantages of the auto-, allo- and xenografts, synthetic bone graft use is slowly increasing. These have advantages of good osteoconductivity, no ethical or problems of infection and production of these grafts can be unlimited. The disadvantages lies in their lack of osteogenic and osteoinductive properties. One such synthetic material is bioactive glass developed by Hench and West In late 1960s. It is available in particulate as well as putty form. Calciumphosphosilicate (CPS) putty (NOVABONE Dental Putty, Novabone products Pvt. Ltd., INDIA) is a new next generation bone graft material built with bioactive glass platform with additives like polyethylene glycol and glycerin to improve handling and efficiency. It is available as a premixed pliable cohesive material. It's not only an osteoconductive material but also imparts osteostimulative effect. CPS putty stimulates osteoblast recruitment, proliferation and differentiation at the defect site and increases rate of bone formation throughout the defect, simultaneously increasing the resorption rate of the graft material. Bembi et al. reported that mean percentage change in amount of radiographic bone fill was more in the treatment of intrabony defects with novabone putty as compared to calcified algae- derived porous hydroxyapatite bone graft. In another study Biswas et al. concluded that use of bioactive glass osteostimulative biomaterial yields superior clinical results, including increased pocket depth reduction of class II furcation defects as compared to an autologous platelet concentrate. Controversial reports have been reported on outcomes of healing in reference to number of bony walls remaining. Therefore type of periodontal defect might influence the effect of grafts and membrane on periodontal regeneration. Contained intrabony periodontal defects (3- walled) offer a higher predictability in the regenerative procedures as compared to non-contained infrabony periodontal defects (1-,2- wall defects) as the later morphology is complex due to limited buccal and lingual periodontal tissue component. The one wall periodontal defect offers less favorable support to the flap and clot stabilization,. Studies have shown considerable variations of results as these defects have larger width (as compared to 3-wall defects); osteoconductivity is difficult to obtain; blood supply to the gingival flap at the graft site is insufficient and gingival recession tends to occur. Selvig et al. reported that the percentage of 3-wall intrabony defect was less than 30% and a combination of 1-wall and 2- wall defects was mainly observed. The prevalence of later is more hence development of predictable periodontal regeneration holds a greater importance in these cases. MATERIALS AND METHODS STUDY DESIGN This randomized controlled study will be conducted in Department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak. STUDY POPULATION Patients will be recruited from regular outpatient department of the Department of Periodontics and Oral Implantology and Department of Oral medicine, Diagnosis and Radiology. The study population will consist of a minimum of 36 systemically healthy patients aged 28 to 60 years with chronic periodontitis and having at least one tooth with non-contained periodontal osseous defect (1-wall, 2-wall defect). In each patient, one non-contained bone defect will be selected, in case of more than one defect, the defect which is at the deepest in the radiographic and clinical examination will be selected, without stratification by tooth type or location. Patients will be randomized into two groups (minimum 18 each) into test and control group. Control group will undergo treatment with open flap debridement (OFD) and intramarrow penetration (IMP) (OFD+IMP; control group) and test group OFD plus IMP plus calcium phosphosilicate putty (CPS) (OFD+IMP+CPS; test group). Prior written informed consent will be taken from all the participants after explaining the study objectives and procedures in patient's own language. METHODOLOGY The study will be conducted as follows: Presurgical therapy: which will include: i. Oral hygiene instructions ii. Full mouth supragingival and subgingival scaling and root planning with ultrasonic scaler, hand scaler and curettes. Subjects will be re-evaluated and those satisfying the inclusion criteria will be recruited CLINICAL PARAMETERS Assessed Using UNC 15 periodontal probe to measure PPD, CAL, BOP, REC at 6 sites (mesial, distal, median points at buccal and lingual aspects) per tooth and at 4 sites per tooth to measure PI, GI. Full mouth indices to be recorded at baseline Bleeding on probing (BOP) Probing Pocket depth (PPD) Clinical Attachment loss (CAL) Site specific indices (6 sites per tooth) Plaque index (PI) Gingival index (GI) Probing Pocket depth (PPD) - measured from gingival margin to the base of pocket Clinical attachment loss (CAL) - measured from cementoenamel junction(CEJ) to base of the pocket Keratinized tissue width (KTW) - distance from gingival margin to mucogingival junction (MGJ) Gingival recession (REC) - distance in millimetres from the gingival margin to CEJ Bleeding on probing (BOP) Tooth mobility RADIOGRAPHIC PARAMETERS: Customized bite blocks and long cone paralleling technique will be used to obtain standardized radiographs. Radiographic defect depth (rDD) - the distance from the projection on the root surface of the most coronal point of the residual bone crest to the bottom of the defect. Radiographic defect width (rDW) - the distance from the most coronal point of the residual bone crest to the root surface, were measured using a caliper and recorded to the nearest mm. Radiographic defect angle (ANG) - line tangential to the root surface and a line connecting the bottom of the defect to the most coronal part of the crest next to the adjacent tooth. All radiographic parameters will be analyzed at baseline, at 6 months and at 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group OFD+IMP+CPS
Arm Type
Experimental
Arm Description
OFD+IMP+CPS; open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty (CPS)
Arm Title
Control group (OFD+IMP)
Arm Type
Active Comparator
Arm Description
OFD+IMP;open flap debridement (OFD) and intramarrow penetration (IMP)
Intervention Type
Procedure
Intervention Name(s)
OFD+IMP+CPS
Intervention Description
open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty
Intervention Type
Procedure
Intervention Name(s)
OFD+IMP
Intervention Description
open flap debridement (OFD) and intramarrow penetration (IMP)
Primary Outcome Measure Information:
Title
Bone fill,
Description
bone growth fill in mm
Time Frame
12 months
Title
CAL
Description
clinical attachment level gain in mm
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with chronic periodontitis Presence of non- contained osseous defect Age 28 to 60 years (both males and females) Completed etiological periodontal therapy (oral hygiene instructions and scaling and root planing under local anaesthesia. At re-evaluation full mouth plaque score67 < 1, full mouth bleeding score FMBS <20% Non-smokers (Current and past smokers) Presence of ≥ 2mm of keratinized tissue to allow flap management Tooth defect criteria: Probing pocket depth ≥ 5mm Clinical attachment loss ≥ 5mm Associated with a 1-wall, 2-wall or a combined 1-2 wall osseous defect ≥ 3mm deep located in the interproximal area of single- and multirooted teeth (assessed by transgingival probing and radiograph, further to be confirmed after flap elevation) Tooth mobility ≤ 1 Concerned tooth and adjoining teeth to be vital and without symptoms or signs of endodontic involvement Tooth and adjoining teeth free of caries or inadequate restorations/ unrestorable tooth. Absence of non-working interferences. Interproximal intrabony defects not extending into the furcation area of molar teeth. Exclusion Criteria: Medical conditions interfering with periodontal health or wound healing Systemic illness known to affect the periodontium or outcome of periodontal therapy. Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy. Patients allergic to medication (local anaesthetic, antibiotics, NSAID). Pregnant or lactating women. Fractured/perforated roots. Developing permanent tooth. History of recent periodontal treatment within 6 months prior to study. 3-wall intrabony defects
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SHIKHA TEWARI, MDS
Phone
9416514600
Email
drshikhatewari@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SHIVALI SAHARAN
Organizational Affiliation
Post Graduate Institute of Dental ISciences, rohtak
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shikha Tewari
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHIKHA TEWARI
Phone
9416514600
Email
drshikhatewari@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Decortication With Calcium Phosphosilicate Putty in the Treatment of Non-contained Intrabony Periodontal Defects

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