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Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients

Primary Purpose

Periodontitis, Adult

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Fixed Orthodontic treatment
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Adult focused on measuring ORTHODONTIC PERIODONTAL MANAGEMENT

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy patients.
  • Adult patients (20-40 years) with periodontally compromised dentition indicated for periodontal surgical intervention.
  • Class I malocclusion that needs orthodontic treatment.
  • Stage II and Stage III periodontitis according to the criteria of 2017 world workshop.

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
  • Noncompliance to oral hygiene measures after Phase I therapy.
  • Presence of trauma from occlusion (TFO).
  • Stage IV periodontitis according to the criteria of 2017 world workshop

Sites / Locations

  • Post Graduate Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 EARLY

Group 2 DELAYED

Arm Description

In experimental group Orthodontic treatment will be started (early) 10 days after periodontal surgery

control group will receive orthodontic intervention(delayed) 3 months after periodontal surgery

Outcomes

Primary Outcome Measures

Pocket depth
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
Pocket depth
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
Pocket depth
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
alveolar crest bone level
alveolar crest bone level using cone beam computed tomography (CBCT) between the two groups, with one group beginning orthodontic treatment 10 days and the second group 3 months after undergoing periodontal surgical treatment.
alveolar crest bone level
alveolar crest bone level using cone beam computed tomography (CBCT) between the two groups, with one group beginning orthodontic treatment 10 days and the second group 3 months after undergoing periodontal surgical treatment.
Clinical attachment loss (CAL)
Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket
Clinical attachment loss (CAL)
Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket
Clinical attachment loss (CAL)
Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket

Secondary Outcome Measures

Bleeding on probing,
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Bleeding on probing,
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Bleeding on probing,
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Plaque index
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Plaque index
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Plaque index
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Gingival Index
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963
Gingival Index
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963
Gingival Index
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963

Full Information

First Posted
June 20, 2022
Last Updated
May 11, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05466253
Brief Title
Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients
Official Title
Effects of Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RESEARCH QUESTION: Will there be a difference in periodontal health of two groups of periodontally compromised orthodontic patients with early and delayed start of orthodontic treatment after periodontal surgery? Population: Adult orthodontic patients with periodontally compromised dentition requiring periodontal surgical management Intervention: Fixed orthodontic treatment started 10 days after periodontal surgery Control group: Fixed orthodontic treatment started 3 months after periodontal surgery Outcomes: changes in osseous (Alveolar bone level) and non-osseous (PI, GI, BOP, PD, CAL) periodontal parameters of the teeth involved in periodontal surgery. Time frame: One year and four months Study Design: Prospective, randomized controlled clinical trial. Specific: Yes Measurable: Yes Achievable: Yes Relevant: Yes Time: One year and four months Feasible: Trained staff, infrastructure, time, study design Interesting: A new treatment protocol will be investigated. Novel: No study comparing these waiting time intervals after periodontal surgery before starting orthodontic treatment. Ethical: Yes Relevant: As there is no clarity on waiting period after periodontally surgery in periodontally compromised adult patients, this study will be of great help in establishing treatment management protocol of such patients.
Detailed Description
Sample size: The CAL difference of 1.07 mm was considered to be of clinical importance between the test and control groups. To be able to detect a clinically meaningful difference in mean CAL of 1.0 mm between groups, standard deviation of 1.0 mm, with a power of 80% and an alpha-level at 0.05, 15 patients are needed in each group. Accounting for a 20% drop out rate 18 patients will be enrolled in each group. Method of study: All the patients included in the study will receive a detailed periodontal evaluation and all periodontal parameters (osseous and non-osseous) will be recorded at the baseline and Phase I periodontal therapy will be provided. This will include oral hygiene instruction, scaling and root planning and re-evaluation after one weeks. If the patients are able to maintain oral hygiene after preliminary periodontal intervention they will be included in further stages of the study. All the patients will receive the indicated periodontal surgical treatment. and the patients will then be randomly divided into two groups - test group and control group Orthodontic treatment will be started in the test group 10 days after periodontal surgery whereas the control group will receive orthodontic intervention 3 months after periodontal surgery. Supragingival scaling will be done in both the groups at 3 month intervals as per requirement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
Keywords
ORTHODONTIC PERIODONTAL MANAGEMENT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All the patients included in the study will receive a detailed periodontal evaluation and all periodontal parameters (osseous and non-osseous) will be recorded at the baseline and Phase I periodontal therapy will be provided. This will include oral hygiene instruction, scaling and root planning and re-evaluation after one weeks. If the patients are able to maintain oral hygiene after preliminary periodontal intervention they will be included in further stages of the study. All the patients will receive the indicated periodontal surgical treatment. and the patients will then be randomly divided into two groups - test group and control group Orthodontic treatment will be started in the test group 10 days after periodontal surgery whereas the control group will receive orthodontic intervention 3 months after periodontal surgery. Supragingival scaling will be done in both the groups at 3 month intervals as per requirement.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 EARLY
Arm Type
Experimental
Arm Description
In experimental group Orthodontic treatment will be started (early) 10 days after periodontal surgery
Arm Title
Group 2 DELAYED
Arm Type
Experimental
Arm Description
control group will receive orthodontic intervention(delayed) 3 months after periodontal surgery
Intervention Type
Procedure
Intervention Name(s)
Fixed Orthodontic treatment
Intervention Description
All the patients will receive the indicated periodontal surgical treatment. and the patients will then be randomly divided into two groups - test group and control group Orthodontic treatment will be started in the test group (EARLY)10 days after periodontal surgery whereas the control group will receive orthodontic intervention (DELAYED) 3 months after periodontal surgery.
Primary Outcome Measure Information:
Title
Pocket depth
Description
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
Time Frame
T0 - baseline records, before beginning of any treatment
Title
Pocket depth
Description
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
Time Frame
T1 - 3 months post periodontal surgery
Title
Pocket depth
Description
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
Time Frame
T2 - one year after start of orthodontic treatment
Title
alveolar crest bone level
Description
alveolar crest bone level using cone beam computed tomography (CBCT) between the two groups, with one group beginning orthodontic treatment 10 days and the second group 3 months after undergoing periodontal surgical treatment.
Time Frame
Alveolar bone level will be recorded with the help of CBCT at T0 intervals.T0 - baseline records, before beginning of any treatment,
Title
alveolar crest bone level
Description
alveolar crest bone level using cone beam computed tomography (CBCT) between the two groups, with one group beginning orthodontic treatment 10 days and the second group 3 months after undergoing periodontal surgical treatment.
Time Frame
Alveolar bone level will be recorded with the help of CBCT at T2 time intervals,T2 - one year after start of orthodontic treatment.
Title
Clinical attachment loss (CAL)
Description
Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket
Time Frame
T0 - baseline records, before beginning of any treatment
Title
Clinical attachment loss (CAL)
Description
Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket
Time Frame
T1 - 3 months post periodontal surgery
Title
Clinical attachment loss (CAL)
Description
Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket
Time Frame
T2 - one year after start of orthodontic treatment
Secondary Outcome Measure Information:
Title
Bleeding on probing,
Description
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Time Frame
T0 - baseline records, before beginning of any treatment
Title
Bleeding on probing,
Description
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Time Frame
T1 3 months post periodontal surgery
Title
Bleeding on probing,
Description
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Time Frame
T2 - one year after start of orthodontic treatment.
Title
Plaque index
Description
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Time Frame
T0 - baseline records, before beginning of any treatment
Title
Plaque index
Description
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Time Frame
T1 3 months post periodontal surgery
Title
Plaque index
Description
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Time Frame
T2 - one year after start of orthodontic treatment.
Title
Gingival Index
Description
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963
Time Frame
T0 - baseline records, before beginning of any treatment
Title
Gingival Index
Description
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963
Time Frame
T1 3 months post periodontal surgery
Title
Gingival Index
Description
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963
Time Frame
T2 - one year after start of orthodontic treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients. Adult patients (20-40 years) with periodontally compromised dentition indicated for periodontal surgical intervention. Class I malocclusion that needs orthodontic treatment. Stage II and Stage III periodontitis according to the criteria of 2017 world workshop. 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 Noncompliance to oral hygiene measures after Phase I therapy. Presence of trauma from occlusion (TFO). Stage IV periodontitis according to the criteria of 2017 world workshop
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients

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