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

NCT05466253 | Completed DMC

• 1 other identifier: PGIDS/BHRC/21/20/ANUNAY
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult

Keywords

ORTHODONTIC PERIODONTAL MANAGEMENT

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• Bleeding on probing,

  T0 - baseline records, before beginning of any treatment

• Bleeding on probing,

  T1 3 months post periodontal surgery

• Bleeding on probing,

  T2 - one year after start of orthodontic treatment.

• Plaque index

  T0 - baseline records, before beginning of any treatment

• Plaque index

  T1 3 months post periodontal surgery

Study Arms (2)

Group 1 EARLY

EXPERIMENTAL

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

Procedure: Fixed Orthodontic treatment

Group 2 DELAYED

EXPERIMENTAL

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

Procedure: Fixed Orthodontic treatment

Interventions

Fixed Orthodontic treatment PROCEDURE

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.

Group 1 EARLY; Group 2 DELAYED

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 20, 2022
• First Posted: July 20, 2022
• Study Start: March 3, 2021
• Primary Completion: November 20, 2022
• Study Completion: December 20, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)