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
Verified date | May 2023 |
Source | Postgraduate Institute of Dental Sciences Rohtak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Dental Sciences | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
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. |
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