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"

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.

Study Overview

• Status: Unknown
• Conditions: Periodontal Bone Loss
• Intervention / Treatment: Procedure: Periodontal and orthodontic treatment; Procedure: periodontal treatment

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

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS,Rohtak
      • Contact: Rekha sharma, mds; Phone Number: 8076190296; Email: rajsringari@gmail.com
      • Contact: meenu gehlot, BDS; Phone Number: 8901329882; Email: meenugehlot82@gmail.com
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: Rekha sharma, mds; Phone Number: 8076190296; Email: rajsringari@gmail.com
      • Contact: meenu gehlot, BDS; Phone Number: 8901329882; Email: meenugehlot82@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .	Procedure: Periodontal and orthodontic treatment; Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment
Active Comparator: control group; Eighteen periodontally compromised patients will receive periodontal treatment alone .	Procedure: periodontal treatment; Eighteen periodontally compromised patients who give be given periodontal treatment alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Study Chair: Rekha Sharma, MDS, PGIDS,Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: meenu ortho

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No