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NCT Number: NCT05466253

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

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.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pocket depth

    Time frame: T0 - baseline records, before beginning of any treatment

    measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre

  2. Pocket depth

    Time frame: T1 - 3 months post periodontal surgery

    measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre

  3. Pocket depth

    Time frame: T2 - one year after start of orthodontic treatment

    measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre

  4. alveolar crest bone level

    Time frame: 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 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.

  5. alveolar crest bone level

    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.

    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.

  6. Clinical attachment loss (CAL)

    Time frame: T0 - baseline records, before beginning of any treatment

    Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket

  7. Clinical attachment loss (CAL)

    Time frame: T1 - 3 months post periodontal surgery

    Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket

  8. Clinical attachment loss (CAL)

    Time frame: T2 - one year after start of orthodontic treatment

    Loss of clinical attachment measured from the Cemento enamel junction to the base of pocket

Secondary outcomes

  1. Bleeding on probing,

    Time frame: T0 - baseline records, before beginning of any treatment

    Bleeding on probing measured at number of sites showing bleeding on using periodontal probe

  2. Bleeding on probing,

    Time frame: T1 3 months post periodontal surgery

    Bleeding on probing measured at number of sites showing bleeding on using periodontal probe

  3. Bleeding on probing,

    Time frame: T2 - one year after start of orthodontic treatment.

    Bleeding on probing measured at number of sites showing bleeding on using periodontal probe

  4. Plaque index

    Time frame: T0 - baseline records, before beginning of any treatment

    Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964

  5. Plaque index

    Time frame: T1 3 months post periodontal surgery

    Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964

  6. Plaque index

    Time frame: T2 - one year after start of orthodontic treatment.

    Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964

  7. Gingival Index

    Time frame: T0 - baseline records, before beginning of any treatment

    Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963

  8. Gingival Index

    Time frame: T1 3 months post periodontal surgery

    Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963

  9. Gingival Index

    Time frame: T2 - one year after start of orthodontic treatment.

    Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2022
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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