Periodontitis, AdultNCT05466253
Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients
A study testing Fixed Orthodontic treatment in people with Periodontitis, Adult, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Fixed Orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 3 Mar 2021to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Adult
- Being tested
- Fixed Orthodontic treatment
- Keywords
- ORTHODONTIC PERIODONTAL MANAGEMENT
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Orthodontic treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 EARLY | Experimental | In experimental group Orthodontic treatment will be started (early) 10 days after periodontal surgery Receives: Procedure: Fixed Orthodontic treatment |
| Group 2 DELAYED | Experimental | control group will receive orthodontic intervention(delayed) 3 months after periodontal surgery Receives: Procedure: Fixed Orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth
measured from the gingival margin to the bottom of the pocket at six sites and recorded to the nearest millimetre
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: T2 - one year after start of orthodontic treatment
Secondary outcomes (9)
Bleeding on probing,
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Measured: 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
Measured: T1 3 months post periodontal surgery
Bleeding on probing,
Bleeding on probing measured at number of sites showing bleeding on using periodontal probe
Measured: 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
Measured: 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
Measured: T1 3 months post periodontal surgery
Plaque index
Plaque index measured using pre specified scoring methods defined by Silness P and Loe H 1964
Measured: 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
Measured: 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
Measured: T1 3 months post periodontal surgery
Gingival Index
Gingival index measured using pre specified scoring methods defined by Loe H and Silness P 1963
Measured: T2 - one year after start of orthodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start3 Mar 2021
- Primary completion20 Nov 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466253
- Sponsor's protocol ID
- PGIDS/BHRC/21/20/ANUNAY
- Status last verified
- May 2023
- First submitted
- 20 Jun 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05466253
- Acronym / sponsor ID
- PGIDS/BHRC/21/20/ANUNAY
- Conditions
- Periodontitis, Adult
- Keywords
- ORTHODONTIC PERIODONTAL MANAGEMENT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 EARLY | Experimental | Procedure: Fixed Orthodontic treatmentIn experimental group Orthodontic treatment will be started (early) 10 days after periodontal surgery |
| Group 2 DELAYED | Experimental | Procedure: Fixed Orthodontic treatmentcontrol group will receive orthodontic intervention(delayed) 3 months after periodontal surgery |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed Orthodontic treatmentAll 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. | Procedure or surgery | Group 1 EARLY, Group 2 DELAYED |
Primary outcome
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
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
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
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.
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.
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
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
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
9 secondary outcomes
Bleeding on probing,
Time frame: T0 - baseline records, before beginning of any treatment
Bleeding on probing,
Time frame: T1 3 months post periodontal surgery
Bleeding on probing,
Time frame: T2 - one year after start of orthodontic treatment.
Plaque index
Time frame: T0 - baseline records, before beginning of any treatment
Plaque index
Time frame: T1 3 months post periodontal surgery
Plaque index
Time frame: T2 - one year after start of orthodontic treatment.
Gingival Index
Time frame: T0 - baseline records, before beginning of any treatment
Gingival Index
Time frame: T1 3 months post periodontal surgery
Gingival Index
Time frame: T2 - one year after start of orthodontic treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed Orthodontic treatment in people with Periodontitis, Adult, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth (time frame: T0 - baseline records, before beginning of any treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.