Periodontal Bone LossNCT03435757
Decortication With Calcium Phosphosilicate Putty in the Treatment of Non-contained Intrabony Periodontal Defects
A study testing OFD+IMP+CPS and OFD+IMP in people with Periodontal Bone Loss, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss
- What is being tested?
- OFD+IMP+CPS and OFD+IMP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2017to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Developing permanent tooth.
- History of recent periodontal treatment within 6 months prior to study.
- 3-wall intrabony defects
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Shikha Tewari
Rohtak, Haryana, 124001
SHIKHA TEWARI, 9416514600, drshikhatewari@yahoo.com
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Periodontal Bone Loss
- Being tested
- OFD+IMP+CPS, OFD+IMP
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFD+IMP+CPSProcedure or surgery
open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty
OFD+IMPProcedure or surgery
open flap debridement (OFD) and intramarrow penetration (IMP)
| Study group | Role | What they receive |
|---|---|---|
| Test Group OFD+IMP+CPS | Experimental | OFD+IMP+CPS; open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty (CPS) Receives: Procedure: OFD+IMP+CPS |
| Control group (OFD+IMP) | Active comparator | OFD+IMP;open flap debridement (OFD) and intramarrow penetration (IMP) Receives: Procedure: OFD+IMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fill,
bone growth fill in mm
Measured: 12 months
CAL
clinical attachment level gain in mm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Dec 2017
- Primary completionJan 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone LossStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHIVALI SAHARAN, Principal investigator, Post Graduate Institute of Dental ISciences, rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435757
- Sponsor's protocol ID
- shivaliperio
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03435757
- Acronym / sponsor ID
- shivaliperio
- Conditions
- Periodontal Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group OFD+IMP+CPS | Experimental | Procedure: OFD+IMP+CPSOFD+IMP+CPS; open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty (CPS) |
| Control group (OFD+IMP) | Active comparator | Procedure: OFD+IMPOFD+IMP;open flap debridement (OFD) and intramarrow penetration (IMP) |
Who may qualify
- Ages
- 28 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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%
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFD+IMP+CPSopen flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty | Procedure or surgery | Test Group OFD+IMP+CPS |
| OFD+IMPopen flap debridement (OFD) and intramarrow penetration (IMP) | Procedure or surgery | Control group (OFD+IMP) |
Primary outcome
Bone fill,
Time frame: 12 months
bone growth fill in mm
CAL
Time frame: 12 months
clinical attachment level gain in mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHIVALI SAHARAN principal investigator
Post Graduate Institute of Dental ISciences, rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFD+IMP+CPS and OFD+IMP in people with Periodontal Bone Loss, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHIKHA TEWARI, MDS (9416514600, drshikhatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone fill, (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.