Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial
"EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 16, 2019
April 1, 2019
1.3 years
April 11, 2019
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
• Alveolar crest bone level
measured from Cemento- enamel junction to bone crest.
12 months
Clinical attachment level (CAL).
• pocket to cemento- enamel junction .
12 months
Study Arms (2)
Test group
EXPERIMENTALEighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .
control group
ACTIVE COMPARATOREighteen periodontally compromised patients will receive periodontal treatment alone .
Interventions
Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment
Eighteen periodontally compromised patients who give be given periodontal treatment alone.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pgids,Rohtak
Rohtak, Haryana, 124001, India
PGIDS
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rekha sharma, MDS
PGIDS,ROHTAK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
April 16, 2019
Study Start
December 1, 2018
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
April 16, 2019
Record last verified: 2019-04