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

Sponsor
Postgraduate Institute of Dental Sciences Rohtak (Other)
Overall Status
Unknown status
CT.gov ID
NCT03914339
Collaborator
(none)
36
2
2
16
18
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Periodontal and orthodontic treatment
  • Procedure: periodontal treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
"EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"
Actual Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. • Alveolar crest bone level [12 months]

    measured from Cemento- enamel junction to bone crest.

  2. Clinical attachment level (CAL). [12 months]

    • pocket to cemento- enamel junction .

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pgids,Rohtak Rohtak Haryana India 124001
2 PGIDS Rohtak Haryana India 124001

Sponsors and Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Study Chair: Rekha sharma, MDS, PGIDS,ROHTAK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier:
NCT03914339
Other Study ID Numbers:
  • meenu ortho
First Posted:
Apr 16, 2019
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2019