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

Periodontitis, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466253
• Other study ID #: PGIDS/BHRC/21/20/ANUNAY
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: May 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

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.

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	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	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
Primary	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
Primary	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
Primary	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,
Primary	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.
Primary	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
Primary	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
Primary	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	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
Secondary	Bleeding on probing,	Bleeding on probing measured at number of sites showing bleeding on using periodontal probe	T1 3 months post periodontal surgery
Secondary	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.
Secondary	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
Secondary	Plaque index	Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964	T1 3 months post periodontal surgery
Secondary	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.
Secondary	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
Secondary	Gingival Index	Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963	T1 3 months post periodontal surgery
Secondary	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.