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

Periodontal Bone Loss Clinical Trial

Official title:

"EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914339
• Other study ID #: meenu ortho
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 2020

Study information

• Verified date: April 2019
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Rekha sharma, MDS
• Phone: 8076190296
• Email: rajsringari[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss

Intervention

Procedure:
• Periodontal and orthodontic treatment
Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment
• periodontal treatment
Eighteen periodontally compromised patients who give be given periodontal treatment alone.

Locations

Country	Name	City	State
India	PGIDS	Rohtak	Haryana
India	Pgids,Rohtak	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Alveolar crest bone level	measured from Cemento- enamel junction to bone crest.	12 months
Primary	Clinical attachment level (CAL).	• pocket to cemento- enamel junction .	12 months