Periodontal Bone LossNCT03914339
Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial
A study testing Periodontal and orthodontic treatment and periodontal treatment in people with Periodontal Bone Loss, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
The main aim of this prospective, randomized controlled clinical study is to: To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss
- What is being tested?
- Periodontal and orthodontic treatment and periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Dec 2018to Apr 2020
- 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
- .• Patient age criteria 20-40 years.
- Periodontally Compromised dentition with moderate to severe periodontitis ≥2 teeth with pocket depth (PD) ≥5 mm and loss of clinical attachment level (CAL) ≥ 4mm. and radiographic bone loss
- Good general health status.
- Malocclusion that needs orthodontic treatment
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(≥5 cigarettes∕ day).
- Noncompliance to oral hygiene measures after Phase I therapy.
- Presence of trauma from occlusion (TFO).
- Patients with aggressive periodontitis
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Pgids,Rohtak
Rohtak, Haryana, 124001
REKHA SHARMA, MDS, 8076190296, rajsringari@gmail.com
meenu gehlot, BDS, 8901329882, meenugehlot82@gmail.com
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Rekha sharma, mds, 8076190296, rajsringari@gmail.com
meenu gehlot, BDS, 8901329882, meenugehlot82@gmail.com
About this study
Official title: "EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"
The main aim of this prospective, randomized controlled clinical study is to:
- To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.
Read the detailed description
All the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. This will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. After an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.Changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam Computed tomography will be taken at the baseline T0 and study end point T2 for assessment of changes in the bone level around maxillary and mandibular teeth
- Conditions
- Periodontal Bone Loss
- Being tested
- Periodontal and orthodontic treatment, periodontal treatment
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal and orthodontic treatmentProcedure or surgery
Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment
periodontal treatmentProcedure or surgery
Eighteen periodontally compromised patients who give be given periodontal treatment alone.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment . Receives: Procedure: Periodontal and orthodontic treatment |
| control group | Active comparator | Eighteen periodontally compromised patients will receive periodontal treatment alone . Receives: Procedure: periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Alveolar crest bone level
measured from Cemento- enamel junction to bone crest.
Measured: 12 months
Clinical attachment level (CAL).
- pocket to cemento- enamel junction .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Dec 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone LossStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rekha sharma, MDS, Study chair, PGIDS,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914339
- Sponsor's protocol ID
- meenu ortho
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"
- ClinicalTrials.gov ID
- NCT03914339
- Acronym / sponsor ID
- meenu ortho
- Conditions
- Periodontal Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 16 Apr 2019 (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.
The main aim of this prospective, randomized controlled clinical study is to:
- To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.
Detailed description
All the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. This will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. After an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.Changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam Computed tomography will be taken at the baseline T0 and study end point T2 for assessment of changes in the bone level around maxillary and mandibular teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Periodontal and orthodontic treatmentEighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment . |
| control group | Active comparator | Procedure: periodontal treatmentEighteen periodontally compromised patients will receive periodontal treatment alone . |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- .• Patient age criteria 20-40 years.
- Periodontally Compromised dentition with moderate to severe periodontitis ≥2 teeth with pocket depth (PD) ≥5 mm and loss of clinical attachment level (CAL) ≥ 4mm. and radiographic bone loss
- Good general health status.
- Malocclusion that needs orthodontic treatment
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(≥5 cigarettes∕ day).
- 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 |
|---|---|---|
| Periodontal and orthodontic treatmentEighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment | Procedure or surgery | Test group |
| periodontal treatmentEighteen periodontally compromised patients who give be given periodontal treatment alone. | Procedure or surgery | control group |
Primary outcome
• Alveolar crest bone level
Time frame: 12 months
measured from Cemento- enamel junction to bone crest.
Clinical attachment level (CAL).
Time frame: 12 months
• pocket to cemento- enamel junction .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Rekha sharma, MDS study chair
PGIDS,ROHTAK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal and orthodontic treatment and periodontal treatment in people with Periodontal Bone Loss, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rekha sharma, MDS (8076190296, rajsringari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Alveolar crest bone level (time frame: 12 months). The study lists 2 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 16 Apr 2019.