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

Effects of Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients - a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis, Adult
• Intervention / Treatment: Procedure: Fixed Orthodontic treatment

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.

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

Contacts and Locations

• Study Contact: Name: Dr Rekha Sharma, MDS; Phone Number: 911 7982391690; Email: rajsringari@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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: Group 1 EARLY; In experimental group Orthodontic treatment will be started (early) 10 days after periodontal surgery	Procedure: Fixed Orthodontic treatment; 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.
Experimental: Group 2 DELAYED; control group will receive orthodontic intervention(delayed) 3 months after periodontal surgery	Procedure: Fixed Orthodontic treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth	measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre	T0 - baseline records, before beginning of any treatment
Pocket depth	measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre	T1 - 3 months post periodontal surgery
Pocket depth	measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre	T2 - one year after start of orthodontic 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.	Alveolar bone level will be recorded with the help of CBCT at T0 intervals.T0 - baseline records, before beginning of any 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.	Alveolar bone level will be recorded with the help of CBCT at T2 time intervals,T2 - one year after start of orthodontic treatment.
Clinical attachment loss (CAL)	Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket	T0 - baseline records, before beginning of any treatment
Clinical attachment loss (CAL)	Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket	T1 - 3 months post periodontal surgery
Clinical attachment loss (CAL)	Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket	T2 - one year after start of orthodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing,	Bleeding on probing measured at number of sites showing bleeding on using periodontal probe	T0 - baseline records, before beginning of any treatment
Bleeding on probing,	Bleeding on probing measured at number of sites showing bleeding on using periodontal probe	T1 3 months post periodontal surgery
Bleeding on probing,	Bleeding on probing measured at number of sites showing bleeding on using periodontal probe	T2 - one year after start of orthodontic treatment.
Plaque index	Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964	T0 - baseline records, before beginning of any treatment
Plaque index	Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964	T1 3 months post periodontal surgery
Plaque index	Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964	T2 - one year after start of orthodontic treatment.
Gingival Index	Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963	T0 - baseline records, before beginning of any treatment
Gingival Index	Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963	T1 3 months post periodontal surgery
Gingival Index	Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963	T2 - one year after start of orthodontic treatment.

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: ORTHODONTIC PERIODONTAL MANAGEMENT
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: PGIDS/BHRC/21/20/ANUNAY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No