Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial
Primary Purpose
Periodontal Bone Loss
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Periodontal and orthodontic treatment
periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss
Eligibility Criteria
Inclusion Criteria
.• Patient age criteria 20-40 years.
- Periodontally Compromised dentition with moderate to severe periodontitis ≥2 teeth with pocket depth (PD) ≥5 mm and loss of clinical attachment level (CAL) ≥ 4mm. and radiographic bone loss
- Good general health status.
- Malocclusion that needs orthodontic treatment
Exclusion Criteria:
- Systemic illness known to affect the periodontium or outcome of periodontal and orthodontic 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.
- Pregnant or lactating women.
- Smokers(≥5 cigarettes∕ day).
- Noncompliance to oral hygiene measures after Phase I therapy.
- Presence of trauma from occlusion (TFO).
- Patients with aggressive periodontitis
Sites / Locations
- Pgids,RohtakRecruiting
- PGIDSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
control group
Arm Description
Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .
Eighteen periodontally compromised patients will receive periodontal treatment alone .
Outcomes
Primary Outcome Measures
• Alveolar crest bone level
measured from Cemento- enamel junction to bone crest.
Clinical attachment level (CAL).
• pocket to cemento- enamel junction .
Secondary Outcome Measures
Full Information
NCT ID
NCT03914339
First Posted
April 11, 2019
Last Updated
April 11, 2019
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03914339
Brief Title
Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial
Official Title
"EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (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
The main aim of this prospective, randomized controlled clinical study is to:
• To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.
Detailed Description
All the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. This will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. After an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.Changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam Computed tomography will be taken at the baseline T0 and study end point T2 for assessment of changes in the bone level around maxillary and mandibular teeth
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
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Eighteen periodontally compromised patients will receive periodontal treatment alone .
Intervention Type
Procedure
Intervention Name(s)
Periodontal and orthodontic treatment
Intervention Description
Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment
Intervention Type
Procedure
Intervention Name(s)
periodontal treatment
Intervention Description
Eighteen periodontally compromised patients who give be given periodontal treatment alone.
Primary Outcome Measure Information:
Title
• Alveolar crest bone level
Description
measured from Cemento- enamel junction to bone crest.
Time Frame
12 months
Title
Clinical attachment level (CAL).
Description
• pocket to cemento- enamel junction .
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
.• Patient age criteria 20-40 years.
Periodontally Compromised dentition with moderate to severe periodontitis ≥2 teeth with pocket depth (PD) ≥5 mm and loss of clinical attachment level (CAL) ≥ 4mm. and radiographic bone loss
Good general health status.
Malocclusion that needs orthodontic treatment
Exclusion Criteria:
Systemic illness known to affect the periodontium or outcome of periodontal and orthodontic 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.
Pregnant or lactating women.
Smokers(≥5 cigarettes∕ day).
Noncompliance to oral hygiene measures after Phase I therapy.
Presence of trauma from occlusion (TFO).
Patients with aggressive periodontitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rekha sharma, MDS
Phone
8076190296
Email
rajsringari@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
meenu gehlot, BDS
Phone
8901329882
Email
meenugehlot82@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha sharma, MDS
Organizational Affiliation
PGIDS,ROHTAK
Official's Role
Study Chair
Facility Information:
Facility Name
Pgids,Rohtak
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REKHA SHARMA, MDS
Phone
8076190296
Email
rajsringari@gmail.com
First Name & Middle Initial & Last Name & Degree
meenu gehlot, BDS
Phone
8901329882
Email
meenugehlot82@gmail.com
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rekha sharma, mds
Phone
8076190296
Email
rajsringari@gmail.com
First Name & Middle Initial & Last Name & Degree
meenu gehlot, BDS
Phone
8901329882
Email
meenugehlot82@gmail.com
12. IPD Sharing Statement
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Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial
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