Gingival HyperplasiaNCT07115784
Clinical Efficacy of Chlorhexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White Spot Lesions in Orthodontic Patients
A study testing Chlorhexidine Varnish in people with Gingival Hyperplasia and Dental Plaque, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This study investigates whether applying a chlorohexidine varnish (a dental coating) reduces gum overgrowth, plaque buildup, and early tooth decay (white spots) in patients with braces. Each participant's mouth is divided into two sides: one receives the active varnish, and the other receives a placebo. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Hyperplasia, Dental Plaque, Tooth Demineralization
- What is being tested?
- Chlorhexidine Varnish
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Jul 2025to 15 Feb 2026
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 15-30 years
- Subjects of both genders
- Presence of permanent dentition
Who cannot join
- Craniofacial anomalies (cleft lip or palate)
- Pregnant and lactating mothers
- Patients at higher risk of drug allergies (antibiotics, anticoagulants, immunosuppressants, calcium channel blockers)
- Allergy to any component of the varnishes
- Mouth breathers
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sardar Begum Dental College & Hospital
Peshawar, Khyber Pakhtunkhwa, 09152
About this study
Official title: Clinical Efficacy of Chlorohexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White-Spot Lesions in Orthodontic Patients: A Split-Mouth Randomised Controlled Trial
This study investigates whether applying a chlorohexidine varnish (a dental coating) reduces gum overgrowth, plaque buildup, and early tooth decay (white spots) in patients with braces. Each participant's mouth is divided into two sides: one receives the active varnish, and the other receives a placebo. Changes in gum health, plaque, and white spots are tracked over 3 months.
Read the detailed description
This split-mouth randomized controlled trial evaluates the clinical efficacy of 40% chlorohexidine varnish in reducing gingival hyperplasia, plaque buildup, and white spot lesions (WSLs) among orthodontic patients aged 15-30 years. The study employs a within patient design. Each participant's upper dental arch is divided into contralateral quadrants, randomly assigned (via coin flip) to receive either experimental (40% chlorohexidine varnish) or control (placebo: 60% sandarac/40% ethanol) treatments. The varnish is applied to buccal tooth surfaces and gingival margins at baseline (pre-bonding) and monthly for 3 months. Participants are blinded to treatment assignments and instructed to avoid eating/drinking for 3 hours post-application. Primary outcomes include gingival hyperplasia (Bokenkamp index), plaque accumulation.
The trial targets 22 participants (44 teeth sites), accounting for a 10% non-response rate, recruited from the Orthodontics Department of Sardar Begum Dental College (Peshawar). Exclusion criteria include craniofacial anomalies, pregnancy/lactation, drug allergies ( antibiotics, immunosuppressants), varnish component sensitivity, or mouth breathing. The study addresses a critical need for preventive oral care in orthodontics, where fixed appliances increase plaque retention and demineralization risks.
- Conditions
- Gingival Hyperplasia, Dental Plaque, Tooth Demineralization
- Being tested
- Chlorhexidine Varnish, Placebo Varnish
- Keywords
- Gingival Hyperplasia, Dental Plaque, Enamel decalcification, Gingival overgrowth
- Medical subject headings
- Gingival Hyperplasia, Dental Plaque, Tooth Demineralization, Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine VarnishDrug
A 40% chlorhexidine varnish formulation (40% chlorhexidine, 36% sandarac, 24% ethanol) applied topically to the buccal surfaces of teeth in the selected upper quadrant. The varnish is applied using a blunt needle syringe before bonding and at monthly follow-up visits for three months. Teeth are dried before application, and patients are instructed not to eat or drink for 3 hours and to avoid brushing until the next day.
Placebo VarnishDrug
A placebo varnish composed of 60% sandarac and 40% ethanol applied topically in the same manner and frequency as the chlorhexidine varnish. Used on the opposite quadrant of the same patient in a split-mouth design. Participants are blinded to whether chlorhexidine or placebo was applied.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Varnish | Experimental | Participants receive 40% chlorhexidine varnish applied to one upper quadrant. The varnish formulation includes 40% chlorhexidine, 36% sandarac, and 24% ethanol. It is applied using a blunt syringe to the buccal surfaces around orthodontic brackets before bonding and during each monthly follow-up for 3 months. Teeth are dried with compressed air prior to application, and patients are advised not to eat/drink for 3 hours and to avoid brushing until the next day. Receives: Drug: Chlorhexidine Varnish |
| Placebo Varnish (Control Arm) | Active comparator | Participants receive placebo varnish (containing 60% sandarac and 40% ethanol) applied to the opposite upper quadrant using the same technique and schedule as the intervention arm. This serves as the control in the split-mouth design. Patients are blinded to which side received the active or placebo varnish. Receives: Drug: Placebo Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Gingival Hyperplasia
Change in gingival hyperplasia score from baseline (T0) to 3 months (T3), assessed using the Bokenkamp Index.
Scale range: 0 to 3
Interpretation:
0 = No gingival overgrowth
- = Mild overgrowth
- = Moderate overgrowth
- = Severe overgrowth Direction: Higher scores indicate worse gingival hyperplasia; a reduction in score reflects clinical improvement.
Measured: Baseline (T0) to 3 months (T3)
Secondary outcomes (2)
Reduction in Plaque Accumulation
Change in plaque index scores from baseline (T0) to 3 months (T3), assessed using the Silness and Löe Plaque Index.
Scale range: 0 to 3
Interpretation:
0 = No plaque
- = Thin film of plaque (visible only on probing)
- = Moderate accumulation visible to the naked eye
- = Abundant plaque accumulation Direction: Higher scores indicate worse plaque accumulation; a reduction in score reflects improvement in oral hygiene.
Measured: Baseline (T0) to 3 months (T3)
Reduction in White Spot Lesion Severity
Change in white spot lesion score from baseline (T0) to 3 months (T3), assessed using the Gorelick Index.
Scale range: 0 to 3
Interpretation:
0 = No white spot lesion
- = Slight white spot formation
- = Excessive white spot formation
- = White spot formation with cavitation Direction: Higher scores indicate more severe enamel demineralization; a reduction in score reflects improvement.
Measured: Baseline (T0) to 3 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start21 Jul 2025
- Primary completion15 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gingival HyperplasiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a specific type of cross-over design where different interventions are applied to different parts of the mouth in the same individual. Each patient will receive chlorhexidine varnish on one quadrant of the upper arch (experimental group) and placebo on the other quadrant (control group), using random allocation by coin flip.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Gandhara University
- Responsible party
- Sponsor
- Investigators
- Faryal Haider, Principal investigator, Sardar Begum Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115784
- Sponsor's protocol ID
- KMU/DIR/CTU/2025/004
- Status last verified
- May 2026
- First submitted
- 29 Jul 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including scores for gingival index, plaque index, and white spot lesions, will be made available to qualified researchers upon reasonable request for the purpose of secondary analysis,
Publications
Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S44-S67. doi: 10.1111/jcpe.12939.
PubMed 29926492Lara-Carrillo E, Montiel-Bastida NM, Sanchez-Perez L, Alanis-Tavira J. Effect of orthodontic treatment on saliva, plaque and the levels of Streptococcus mutans and Lactobacillus. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e924-9. doi: 10.4317/medoral.15.e924.
PubMed 20383105Grover V, Kapoor A, Malhotra R, Battu VS, Bhatia A, Sachdeva S. To assess the effectiveness of a chlorhexidine chip in the treatment of chronic periodontitis: A clinical and radiographic study. J Indian Soc Periodontol. 2011 Apr;15(2):139-46. doi: 10.4103/0972-124X.84383.
PubMed 21976838Rai P, Pandey RK, Khanna R. Qualitative and Quantitative Effect of a Protective Chlorhexidine Varnish Layer Over Resin-infiltrated Proximal Carious Lesions in Primary Teeth. Pediatr Dent. 2016;38(4):40-5.
PubMed 27557913Bretz WA, Valente MI, Djahjah C, do Valle EV, Weyant RJ, Nor JE. Chlorhexidine varnishes prevent gingivitis in adolescents. ASDC J Dent Child. 2000 Nov-Dec;67(6):399-402, 374.
PubMed 11204062Alavi S, Yaraghi N. The effect of fluoride varnish and chlorhexidine gel on white spots and gingival and plaque indices in fixed orthodontic patients: A placebo-controlled study. Dent Res J (Isfahan). 2018 Jul-Aug;15(4):276-282.
PubMed 30123305
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Chlorohexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White-Spot Lesions in Orthodontic Patients: A Split-Mouth Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07115784
- Acronym / sponsor ID
- KMU/DIR/CTU/2025/004
- Conditions
- Gingival Hyperplasia, Dental Plaque, Tooth Demineralization
- Keywords
- Gingival Hyperplasia, Dental Plaque, Enamel decalcification, Gingival overgrowth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Gandhara University
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 11 Aug 2025 (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.
This study investigates whether applying a chlorohexidine varnish (a dental coating) reduces gum overgrowth, plaque buildup, and early tooth decay (white spots) in patients with braces. Each participant's mouth is divided into two sides: one receives the active varnish, and the other receives a placebo. Changes in gum health, plaque, and white spots are tracked over 3 months.
Detailed description
This split-mouth randomized controlled trial evaluates the clinical efficacy of 40% chlorohexidine varnish in reducing gingival hyperplasia, plaque buildup, and white spot lesions (WSLs) among orthodontic patients aged 15-30 years. The study employs a within patient design. Each participant's upper dental arch is divided into contralateral quadrants, randomly assigned (via coin flip) to receive either experimental (40% chlorohexidine varnish) or control (placebo: 60% sandarac/40% ethanol) treatments. The varnish is applied to buccal tooth surfaces and gingival margins at baseline (pre-bonding) and monthly for 3 months. Participants are blinded to treatment assignments and instructed to avoid eating/drinking for 3 hours post-application. Primary outcomes include gingival hyperplasia (Bokenkamp index), plaque accumulation.
The trial targets 22 participants (44 teeth sites), accounting for a 10% non-response rate, recruited from the Orthodontics Department of Sardar Begum Dental College (Peshawar). Exclusion criteria include craniofacial anomalies, pregnancy/lactation, drug allergies ( antibiotics, immunosuppressants), varnish component sensitivity, or mouth breathing. The study addresses a critical need for preventive oral care in orthodontics, where fixed appliances increase plaque retention and demineralization risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a specific type of cross-over design where different interventions are applied to different parts of the mouth in the same individual. Each patient will receive chlorhexidine varnish on one quadrant of the upper arch (experimental group) and placebo on the other quadrant (control group), using random allocation by coin flip.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Varnish | Experimental | Drug: Chlorhexidine VarnishParticipants receive 40% chlorhexidine varnish applied to one upper quadrant. The varnish formulation includes 40% chlorhexidine, 36% sandarac, and 24% ethanol. It is applied using a blunt syringe to the buccal surfaces around orthodontic brackets before bonding and during each monthly follow-up for 3 months. Teeth are dried with compressed air prior to application, and patients are advised not to eat/drink for 3 hours and to avoid brushing until the next day. |
| Placebo Varnish (Control Arm) | Active comparator | Drug: Placebo VarnishParticipants receive placebo varnish (containing 60% sandarac and 40% ethanol) applied to the opposite upper quadrant using the same technique and schedule as the intervention arm. This serves as the control in the split-mouth design. Patients are blinded to which side received the active or placebo varnish. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 15-30 years
- Subjects of both genders
- Presence of permanent dentition
Key exclusion criteria (5 listed)
- Craniofacial anomalies (cleft lip or palate)
- Pregnant and lactating mothers
- Patients at higher risk of drug allergies (antibiotics, anticoagulants, immunosuppressants, calcium channel blockers)
- Allergy to any component of the varnishes
- Mouth breathers
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 VarnishA 40% chlorhexidine varnish formulation (40% chlorhexidine, 36% sandarac, 24% ethanol) applied topically to the buccal surfaces of teeth in the selected upper quadrant. The varnish is applied using a blunt needle syringe before bonding and at monthly follow-up visits for three months. Teeth are dried before application, and patients are instructed not to eat or drink for 3 hours and to avoid brushing until the next day. | Drug | Chlorhexidine Varnish |
| Placebo VarnishA placebo varnish composed of 60% sandarac and 40% ethanol applied topically in the same manner and frequency as the chlorhexidine varnish. Used on the opposite quadrant of the same patient in a split-mouth design. Participants are blinded to whether chlorhexidine or placebo was applied. | Drug | Placebo Varnish (Control Arm) |
Primary outcome
Reduction in Gingival Hyperplasia
Time frame: Baseline (T0) to 3 months (T3)
Change in gingival hyperplasia score from baseline (T0) to 3 months (T3), assessed using the Bokenkamp Index. Scale range: 0 to 3 Interpretation: 0 = No gingival overgrowth 1. = Mild overgrowth 2. = Moderate overgrowth 3. = Severe overgrowth Direction: Higher scores indicate worse gingival hyperplasia; a reduction in score reflects clinical improvement.
2 secondary outcomes
Reduction in Plaque Accumulation
Time frame: Baseline (T0) to 3 months (T3)
Reduction in White Spot Lesion Severity
Time frame: Baseline (T0) to 3 months (T3)
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 7 May 2026.
- Background: PubMed 29926492Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S44-S67. doi: 10.1111/jcpe.12939.
- Background: PubMed 20383105Lara-Carrillo E, Montiel-Bastida NM, Sanchez-Perez L, Alanis-Tavira J. Effect of orthodontic treatment on saliva, plaque and the levels of Streptococcus mutans and Lactobacillus. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e924-9. doi: 10.4317/medoral.15.e924.
- Background: PubMed 21976838Grover V, Kapoor A, Malhotra R, Battu VS, Bhatia A, Sachdeva S. To assess the effectiveness of a chlorhexidine chip in the treatment of chronic periodontitis: A clinical and radiographic study. J Indian Soc Periodontol. 2011 Apr;15(2):139-46. doi: 10.4103/0972-124X.84383.
- Background: PubMed 27557913Rai P, Pandey RK, Khanna R. Qualitative and Quantitative Effect of a Protective Chlorhexidine Varnish Layer Over Resin-infiltrated Proximal Carious Lesions in Primary Teeth. Pediatr Dent. 2016;38(4):40-5.
- Background: PubMed 11204062Bretz WA, Valente MI, Djahjah C, do Valle EV, Weyant RJ, Nor JE. Chlorhexidine varnishes prevent gingivitis in adolescents. ASDC J Dent Child. 2000 Nov-Dec;67(6):399-402, 374.
- Background: PubMed 30123305Alavi S, Yaraghi N. The effect of fluoride varnish and chlorhexidine gel on white spots and gingival and plaque indices in fixed orthodontic patients: A placebo-controlled study. Dent Res J (Isfahan). 2018 Jul-Aug;15(4):276-282.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including scores for gingival index, plaque index, and white spot lesions, will be made available to qualified researchers upon reasonable request for the purpose of secondary analysis,
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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.
Faryal Haider principal investigator
Sardar Begum Dental College
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 Varnish in people with Gingival Hyperplasia and Dental Plaque, run by Khyber Medical University Peshawar 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 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 7 May 2026. 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. 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?
Reduction in Gingival Hyperplasia (time frame: Baseline (T0) to 3 months (T3)). 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 NCT07115784, which also lists 6 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 7 May 2026.