GingivitisNCT06305546
Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients
A study testing Chlorhexidine Gluconate, Metronidazole and combination gel (chlorhexidine and metronidazole) in people with Gingivitis, run by Anam Sattar at 1 site in Pakistan.
Trial summary
Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Chlorhexidine Gluconate, Metronidazole and combination gel (chlorhexidine and metronidazole)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 Oct 2023
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between the ages of 16 - 35 years with moderate to severe crowding and receiving fixed orthodontic treatment for at least six months were eligible.
- Patients with gingival, and ortho plaque indices ≥ 2 and bleeding index ≥ 1 were also included in the inclusion criteria.
Who cannot join
- systematically unhealthy patients with comorbidities such as blood dyscrasias, rheumatic fever, congenital heart disease, and diabetes mellitus.
- Smokers
- participants who show no motivation to take care of their teeth,
- people with disabilities who are physically dependent in any way.
- Patients with allergies to chlorhexidine and metronidazole,
- women who are pregnant or lactating.
- Patients with clinical attachment loss and calculus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Different Antiplaque Agents On Gingivitis In Patients Undergoing Fixed Orthodontic Treatment: A Double-Blind, Randomized Controlled Trial.
Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis
Read the detailed description
Metal brackets were used on the teeth such as incisors, canines, and premolars as well as bands on the 1st molars to treat all patients with the same kind of orthodontic appliances. Metal Brackets were bonded by the principal investigator with the direct bonding technique by using light cure adhesives. General oral hygiene instructions were given by the clinician to each participant in the study.
Participants were divided into four groups through computer-generated software. Group A participants used 1% metronidazole gel, Group B participants used 0.25% chlorhexidine gel. Group C participants used a combination gel (1% Metronidazole and 0.25% Chlorhexidine). Group D participants used a placebo gel. All participants were instructed to follow oral hygiene measures such as brushing twice a day with a soft brush with fluoridated toothpaste, and use of floss or interdental brushes. For two weeks, all individuals from groups A, B, C, and D were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, the investigators assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
OUTCOMES:
The primary outcome included the measurement of indices during study time from baseline (T0) to 2weeks (T1), 4 weeks (T2), 8 weeks (T3) and 12 weeks(T4) . The investigators have evaluated Gingival Index and Bleeding Index by probing and assessing the gingiva and Orthodontic Plaque index by plaque disclosing tablets, and examined six standard sites on incisors, canine, and premolars as described by Gettinger et al. Banded first molars were not included because banding itself can compromise periodontal health. The study sites were assessed by using CPITN probe. Six proximal line angles were investigated for gingivitis on the selected teeth: Right maxillary second premolar, mesiobuccal line angle; right maxillary canine, distobuccal line angle; left maxillary central incisor, distopalatal line angle; right mandibular central incisor, distolingual line angle; left mandibular canine, distobuccal line angle; left mandibular second premolar, mesiobuccal line angle.
If any of the study teeth were missing, then the corresponding tooth on the opposite side was evaluated.
Patients were only included in the trial if they have Gingival index, Orthodontic plaque index scores ≥2 and Bleeding index ≥ 1 on any three or more than three of the six teeth that were examined in the study. The total combined GI and BI indexes were computed by averaging the measured values at T0, T1, T2, T3 and T4 . For OPI, the score was calculated by counting the number of teeth with plaque accumulation at each time interval.
- Conditions
- Gingivitis
- Being tested
- Chlorhexidine Gluconate, Metronidazole, combination gel (chlorhexidine and metronidazole), Placebo
- Keywords
- gingivitis,, fixed orthodontic treatment,, anti plaque gels
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Also called CHX
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
MetronidazoleDrug
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
combination gel (chlorhexidine and metronidazole)Drug
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
PlaceboDrug
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Drug: Chlorhexidine Gluconate |
| GROUP B | Experimental | Not described Receives: Drug: Metronidazole |
| GROUP C | Experimental | Not described Receives: Drug: combination gel (chlorhexidine and metronidazole) |
| GROUP D | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index
Gingival index Score 0: no inflammation Score 1: Mild inflammation of gingiva. No bleeding on probing. Score2: Moderate inflammation, Red, edematous and shiny gingiva, bleeding on probing.
Score 3: Severe inflammation, Red, edematous and ulcerated gingiva. There is spontaneous bleeding
Measured: 12 weeks
bleeding index
Bleeding Index Score 0: absence of bleeding after 30 seconds Score 1: presence of bleeding after 30 seconds Score 2: immediate bleeding
Measured: 12 weeks
orthodontic plaque index
Orthodontic Plaque Index 0: No plaque deposits on the tooth surfaces surrounding the bracket base
- Plaque deposits on one tooth surface at the bracket base
- Plaque deposits on two tooth surfaces at the bracket base
- Plaque deposits on three tooth surfaces at the bracket base
- Plaque deposits on four tooth surfaces at the bracket base
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anam Sattar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anam Sattar, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305546
- Sponsor's protocol ID
- 2911
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Different Antiplaque Agents On Gingivitis In Patients Undergoing Fixed Orthodontic Treatment: A Double-Blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06305546
- Acronym / sponsor ID
- 2911
- Conditions
- Gingivitis
- Keywords
- gingivitis,, fixed orthodontic treatment,, anti plaque gels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Anam SattarUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 12 Mar 2024 (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.
Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis
Detailed description
Metal brackets were used on the teeth such as incisors, canines, and premolars as well as bands on the 1st molars to treat all patients with the same kind of orthodontic appliances. Metal Brackets were bonded by the principal investigator with the direct bonding technique by using light cure adhesives. General oral hygiene instructions were given by the clinician to each participant in the study.
Participants were divided into four groups through computer-generated software. Group A participants used 1% metronidazole gel, Group B participants used 0.25% chlorhexidine gel. Group C participants used a combination gel (1% Metronidazole and 0.25% Chlorhexidine). Group D participants used a placebo gel. All participants were instructed to follow oral hygiene measures such as brushing twice a day with a soft brush with fluoridated toothpaste, and use of floss or interdental brushes. For two weeks, all individuals from groups A, B, C, and D were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, the investigators assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
OUTCOMES:
The primary outcome included the measurement of indices during study time from baseline (T0) to 2weeks (T1), 4 weeks (T2), 8 weeks (T3) and 12 weeks(T4) . The investigators have evaluated Gingival Index and Bleeding Index by probing and assessing the gingiva and Orthodontic Plaque index by plaque disclosing tablets, and examined six standard sites on incisors, canine, and premolars as described by Gettinger et al. Banded first molars were not included because banding itself can compromise periodontal health. The study sites were assessed by using CPITN probe. Six proximal line angles were investigated for gingivitis on the selected teeth: Right maxillary second premolar, mesiobuccal line angle; right maxillary canine, distobuccal line angle; left maxillary central incisor, distopalatal line angle; right mandibular central incisor, distolingual line angle; left mandibular canine, distobuccal line angle; left mandibular second premolar, mesiobuccal line angle.
If any of the study teeth were missing, then the corresponding tooth on the opposite side was evaluated.
Patients were only included in the trial if they have Gingival index, Orthodontic plaque index scores ≥2 and Bleeding index ≥ 1 on any three or more than three of the six teeth that were examined in the study. The total combined GI and BI indexes were computed by averaging the measured values at T0, T1, T2, T3 and T4 . For OPI, the score was calculated by counting the number of teeth with plaque accumulation at each time interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Chlorhexidine Gluconate |
| GROUP B | Experimental | Drug: Metronidazole |
| GROUP C | Experimental | Drug: combination gel (chlorhexidine and metronidazole) |
| GROUP D | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients between the ages of 16 - 35 years with moderate to severe crowding and receiving fixed orthodontic treatment for at least six months were eligible.
- Patients with gingival, and ortho plaque indices ≥ 2 and bleeding index ≥ 1 were also included in the inclusion criteria.
Key exclusion criteria (7 listed)
- systematically unhealthy patients with comorbidities such as blood dyscrasias, rheumatic fever, congenital heart disease, and diabetes mellitus.
- Smokers
- participants who show no motivation to take care of their teeth,
- people with disabilities who are physically dependent in any way.
- Patients with allergies to chlorhexidine and metronidazole,
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 |
|---|---|---|
| Chlorhexidine GluconateAlso: CHXFor two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up. | Drug | group A |
| MetronidazoleFor two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up. | Drug | GROUP B |
| combination gel (chlorhexidine and metronidazole)For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up. | Drug | GROUP C |
| PlaceboFor two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up. | Drug | GROUP D |
Primary outcome
gingival index
Time frame: 12 weeks
Gingival index Score 0: no inflammation Score 1: Mild inflammation of gingiva. No bleeding on probing. Score2: Moderate inflammation, Red, edematous and shiny gingiva, bleeding on probing. Score 3: Severe inflammation, Red, edematous and ulcerated gingiva. There is spontaneous bleeding
bleeding index
Time frame: 12 weeks
Bleeding Index Score 0: absence of bleeding after 30 seconds Score 1: presence of bleeding after 30 seconds Score 2: immediate bleeding
orthodontic plaque index
Time frame: 12 weeks
Orthodontic Plaque Index 0: No plaque deposits on the tooth surfaces surrounding the bracket base 1. Plaque deposits on one tooth surface at the bracket base 2. Plaque deposits on two tooth surfaces at the bracket base 3. Plaque deposits on three tooth surfaces at the bracket base 4. Plaque deposits on four tooth surfaces at the bracket base
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 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 Chlorhexidine Gluconate, Metronidazole and combination gel (chlorhexidine and metronidazole) in people with Gingivitis, run by Anam Sattar at 1 site in Pakistan.
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 2 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 13 Mar 2024. 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 Pakistan. 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. 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.
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?
gingival index (time frame: 12 weeks). The study lists 3 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 13 Mar 2024.