Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial

NCT ID: NCT03914339

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-04-30

Brief Summary

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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

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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

Conditions

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Periodontal Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test group

Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .

Group Type EXPERIMENTAL

Periodontal and orthodontic treatment

Intervention Type PROCEDURE

Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment

control group

Eighteen periodontally compromised patients will receive periodontal treatment alone .

Group Type ACTIVE_COMPARATOR

periodontal treatment

Intervention Type PROCEDURE

Eighteen periodontally compromised patients who give be given periodontal treatment alone.

Interventions

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Periodontal and orthodontic treatment

Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment

Intervention Type PROCEDURE

periodontal treatment

Eighteen periodontally compromised patients who give be given periodontal treatment alone.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rekha sharma, MDS

Role: STUDY_CHAIR

PGIDS,ROHTAK

Locations

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Pgids,Rohtak

Rohtak, Haryana, India

Site Status RECRUITING

PGIDS

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rekha sharma, MDS

Role: CONTACT

8076190296

meenu gehlot, BDS

Role: CONTACT

8901329882

Facility Contacts

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REKHA SHARMA, MDS

Role: primary

8076190296

meenu gehlot, BDS

Role: backup

8901329882

Rekha sharma, mds

Role: primary

8076190296

meenu gehlot, BDS

Role: backup

8901329882

Other Identifiers

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meenu ortho

Identifier Type: -

Identifier Source: org_study_id

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