PeriodontitisPhase 1NCT03410602
Nonsurgical Periodontal Therapy on Banded First Molars
A Phase 1 study testing Full-mouth supragingival scaling, Subgingival scaling and Subgingival irrigation in people with Periodontitis, run by Meenakshi Ammal Dental College and Hospital.
Trial summary
The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Full-mouth supragingival scaling, Subgingival scaling and Subgingival irrigation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 29 Nov 2017
- Phase
- Phase 1
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both male and female patients within the age group 16 to 25 years.
- Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.
- Systemically healthy patients.
Who cannot join
- Congenital malformations in the oral cavity.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Patients using removable orthodontic appliances.
- Patients who were administered antibiotics or other systemic or topical antimicrobial agents.
- Smokers.
About this study
Official title: Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment
The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment.
Read the detailed description
A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and divided into two groups.
Group A comprised of 15 patients who were treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars.
Group B comprised of 15 patients who were treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Treatment for both the groups was performed at 3rd month, 6th month and 9th month.
Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. The differences between the values were assessed and sent for statistical analysis.
- Conditions
- Periodontitis
- Being tested
- Full-mouth supragingival scaling, Subgingival scaling, Subgingival irrigation
- Keywords
- Nonsurgical periodontal therapy, Orthodontic bands
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-mouth supragingival scalingProcedure or surgery
Also called Oral prophylaxis
Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.
Subgingival scalingProcedure or surgery
Also called Deep scaling
Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.
Subgingival irrigationDrug
Also called Chemical plaque control
Test group comprised of 15 patients who were treated with subgingival irrigation only around all banded first molars with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent.
| Study group | Role | What they receive |
|---|---|---|
| Supragingival and subgingival scaling | Placebo comparator | Supragingival and subgingival scaling group comprised of 15 orthodontic patients treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. Receives: Procedure: Full-mouth supragingival scaling; Procedure: Subgingival scaling |
| Subgingival irrigation | Active comparator | Subgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. Receives: Procedure: Full-mouth supragingival scaling; Procedure: Subgingival scaling; Drug: Subgingival irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month
Radiographic evidence of alveolar crestal bone level was measured around each banded first molar
Measured: Baseline to 12th month
Secondary outcomes (4)
Change from baseline plaque index at 12th month
Full-mouth plaque index measurements were carried out at four sites around each tooth (mesiobuccal, buccal, distobuccal and lingual).
Measured: Baseline to 12 month
Change from baseline gingival index at 12th month
The measurements were carried out around all the banded first molars at four sites (mesiobuccal, buccal, distobuccal and lingual).
Measured: Baseline to 12th month
Change from baseline probing pocket depth at 12th month
The probing pocket depth was measured clinically using Williams periodontal probe at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, distolingual and lingual) of each banded first molar.
Measured: Baseline to 12th month
Change from baseline clinical attachment level at 12th month
Clinical attachment level (CAL) was measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket.
Measured: Baseline to 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Apr 2016
- Primary completion30 Aug 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
- Investigators
- Nashra Kareem, BDS, Principal investigator, Meenakshi Ammal Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410602
- Sponsor's protocol ID
- MADC/IRB-IX/2016/153
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babay N, Al Jasser N. Subgingival irrigation effects of chlorhexidine or sanguinarine on gingivitis in orthodontic patients. J Clin Pediatr Dent. 1996 Spring;20(3):225-8.
PubMed 8634210Morrow D, Wood DP, Speechley M. Clinical effect of subgingival chlorhexidine irrigation on gingivitis in adolescent orthodontic patients. Am J Orthod Dentofacial Orthop. 1992 May;101(5):408-13. doi: 10.1016/0889-5406(92)70113-O.
PubMed 1590289
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT03410602
- Acronym / sponsor ID
- MADC/IRB-IX/2016/153
- Conditions
- Periodontitis
- Keywords
- Nonsurgical periodontal therapy, Orthodontic bands
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 25 Jan 2018 (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 aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment.
Detailed description
A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and divided into two groups.
Group A comprised of 15 patients who were treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars.
Group B comprised of 15 patients who were treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Treatment for both the groups was performed at 3rd month, 6th month and 9th month.
Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. The differences between the values were assessed and sent for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supragingival and subgingival scaling | Placebo comparator | Procedure: Full-mouth supragingival scaling, Procedure: Subgingival scalingSupragingival and subgingival scaling group comprised of 15 orthodontic patients treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. |
| Subgingival irrigation | Active comparator | Procedure: Full-mouth supragingival scaling, Procedure: Subgingival scaling, Drug: Subgingival irrigationSubgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Both male and female patients within the age group 16 to 25 years.
- Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.
- Systemically healthy patients.
Key exclusion criteria (5 listed)
- Congenital malformations in the oral cavity.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Patients using removable orthodontic appliances.
- Patients who were administered antibiotics or other systemic or topical antimicrobial agents.
- Smokers.
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 |
|---|---|---|
| Full-mouth supragingival scalingAlso: Oral prophylaxisControl group comprised of 15 patients who were treated with routine full-mouth supragingival scaling. | Procedure or surgery | Subgingival irrigation, Supragingival and subgingival scaling |
| Subgingival scalingAlso: Deep scalingTest group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars. | Procedure or surgery | Subgingival irrigation, Supragingival and subgingival scaling |
| Subgingival irrigationAlso: Chemical plaque controlTest group comprised of 15 patients who were treated with subgingival irrigation only around all banded first molars with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. | Drug | Subgingival irrigation |
Primary outcome
Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month
Time frame: Baseline to 12th month
Radiographic evidence of alveolar crestal bone level was measured around each banded first molar
4 secondary outcomes
Change from baseline plaque index at 12th month
Time frame: Baseline to 12 month
Change from baseline gingival index at 12th month
Time frame: Baseline to 12th month
Change from baseline probing pocket depth at 12th month
Time frame: Baseline to 12th month
Change from baseline clinical attachment level at 12th month
Time frame: Baseline to 12th month
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 26 Jan 2018.
- Background: PubMed 8634210Babay N, Al Jasser N. Subgingival irrigation effects of chlorhexidine or sanguinarine on gingivitis in orthodontic patients. J Clin Pediatr Dent. 1996 Spring;20(3):225-8.
- Background: PubMed 1590289Morrow D, Wood DP, Speechley M. Clinical effect of subgingival chlorhexidine irrigation on gingivitis in adolescent orthodontic patients. Am J Orthod Dentofacial Orthop. 1992 May;101(5):408-13. doi: 10.1016/0889-5406(92)70113-O.
- 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.
Nashra Kareem, BDS principal investigator
Meenakshi Ammal Dental College and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Full-mouth supragingival scaling, Subgingival scaling and Subgingival irrigation in people with Periodontitis, run by Meenakshi Ammal Dental College and Hospital.
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 3 inclusion and 5 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month (time frame: Baseline to 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410602, which also lists 2 linked publications.
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 26 Jan 2018.