Chronic PeriodontitisNCT03169322
Influence of Mouth Breathing on Periodontal Healing
A study testing SRP in people with Chronic Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Studies reveal association between dry conditions and decreased healing in wounds or any treatment. From these studies, it can be hypothesized that healing in mouth breathers after scaling and root planing in terms of bleeding on probing, gingival index, plaque Index, clinical attachment level, probing depth may not… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 14 Oct 2016to Sep 2017
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals possessing ≥ 20 natural teeth.
- Chronic periodontitis criteria as defined by division of Oral Health at the Centre for Disease Control and Prevention(CDC) in collaboration with American Academy of Periodontology(AAP)-(Page and Eke 2012) i.e. at least two or more interproximal sites with clinical attachment loss(CAL) ≥ 4mm(not on same tooth), or ≥2 interproximal sites with Pocket Depth(PD) ≥5 mm(not on same tooth).
- BOP prevalence >25%.
Who cannot join
- Patients on anti-inflammatory drugs or antibiotics within previous 6 months of commencement of study, or on any other regular medication or mouth wash, that is likely to influence periodontal status.
- History of periodontal treatment within 1 year of inclusion in the study.
- Current or former smokers or use of tobacco in any form.
- History of treatment with statins, glucocorticoids, anticoagulants, phenytoin, calcium channel blockers such as nifedipine, diltiazem, verapamil, felodipine; immunosuppressants such as cyclosporine; bisphosphonates or any other host modulatory drugs during last six months.
- Non-plaque-induced gingival lesions.
- Patients taking drugs reported to cause xerostomia such as anti-cholinergics, anti-hypertensives, analgesics, sedatives, tranquilizing agents, antihistamines.
- A recent history of any other acute or chronic infection.
- Pregnant and lactating women and those taking oral contraceptive drugs.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Tewari, 01262283876, principalpgids@yahoo.in
Manpreet Kaur
About this study
Official title: Influence of Mouth Breathing on Outcome of Scaling and Root Planing in Chronic Periodontitis
Studies reveal association between dry conditions and decreased healing in wounds or any treatment. From these studies, it can be hypothesized that healing in mouth breathers after scaling and root planing in terms of bleeding on probing, gingival index, plaque Index, clinical attachment level, probing depth may not show as much improvement as in case of nose breathers. No study has been conducted till date to find effect of scaling and root planing in periodontitis patients among mouth breathers and nose breathers.
Read the detailed description
INTRODUCTION
Mouth breathing is perceived to be responsible for persistant marginal gingivitis. The most common region to be affected by gingivitis in mouth breathers is maxillary anterior region. Other areas are affected in following decreasing order: maxillary posterior areas, mandibular anterior region and mandibular posterior region. Various reasons are considered to be responsible for gingival inflammation in mouth breathers. Possible factors responsible for gingival inflammation may be continuous loss of saliva over marginal tissues leading to increased plaque scores or qualitative change in plaque in terms of incorporation of more virulent strains of bacteria in plaque.
Mouth breathing, lip seal, upper lip coverage are related. In one study, mouth breathing along with incompetent lip seal and decreased upper lip coverage were associated with gingivitis. In other study plaque was thought to be a contributing factor for gingivitis in patients with decreased upper lip coverage. One study showed lack of lip seal due to increased overjet to be responsible for increased gingival inflammation. Kolawole KA et al in their study found that lip incompetence was associated with increased plaque scores. It may be due to lack of normal cleansing action of saliva. No association between mouth breathing and gingivitis prevalence had been reported in the study by Sutcliffe. However mouth breathing slightly increased severity of gingivitis.
Saliva performs very important functions including lubrication of oral tissues, antimicrobial action, regulation of pH, elimination of food bolus and facilitating in removal of carbon. Salivary flow provides mechanical cleansing of residues present in mouth such as non adherent bacteria, cellular and food debris. Lack of salivary flushing action results in accumulation of food debris and dental plaque thus promoting an acidogenic and aciduric oral bacteria responsible for dental caries.
Xerostomia /dry mouth is responsible for increase in gingival inflammation and also affects periodontal conditions with increased probing depth, plaque index. In one study, young adults with self reporting of xerostomia had increased sites with bleeding on probing and increased plaque scores. Proliferative activity of oral gingival epithelium is decreased in inflamed gingiva of patients with xerostomia. In one study, healing in gingivectomy wound was delayed in sialadenectomized rats.
In habitual mouth-breathers, 50% of the inspired air passes through mouth. In mouth-breathers, amount of water evaporated from saliva into air may reach 0.24 mL/min resulting in greater retention of bacteria in oral cavity.
For transient relief of xerostomia, salivary substitutes and sugar free gums and lozenges are available. Effect of salivary substitutes along with scaling and root planing in mouth breathers have been evaluated in one study. It was found that in mouth breathers, scaling and root planing along with application of salivary substitutes provided better improvement in gingival index, bleeding on probing, clinical attachment level than in whom scaling and root planing alone was performed.
Better response of gingiva was seen in mouth breathers after 4-6 weeks of oral debridement and use of petroleum jelly. However when use of petroleum jelly was withheld inflammation was again noticed in gingiva.
Similar effects of drying conditions are seen in various parts of body. In children with dry skin and predisposition to atopic dermatitis, use of emollients was seen to improve their skin conditions.
All these studies reveal association between dry conditions and decreased healing in wounds or any treatment. From these studies, it can be hypothesized that healing in mouth breathers after scaling and root planing in terms of bleeding on probing, gingival index, plaque Index, clinical attachment level, probing depth may not show as much improvement as in case of nose breathers. No study has been conducted till date to find effect of scaling and root planing in periodontitis patients among mouth breathers and nose breathers.
MATERIAL AND METHODS
This study will be conducted in Department of Periodontics, Post Graduate Institute of Dental Sciences(PGIDS), Rohtak.
STUDY POPULATION AND DESIGN
Patients suffering from chronic periodontitis of age group 20-35 years will be recruited from regular OPD of the Department of Periodontics in the study. Approximately 60 patients would comprise test group and control group. Test group (n≈30) will include individuals having mouth breathing habit. Control group (n≈30) will comprise of patients who are nose breathers.
METHODOLOGY
The study will be conducted in accordance with the ethical standards outlined in the 1964 Declaration of Helsinki, as revised in 2013.
Diagnosis of mouth breathing
Diagnosis of mouth breathing will be made on the basis of patient history. Patients would be asked whether, in their opinion, they are mouth breathers, and also whether they have dry mouth on awakening.
Study groups
After carefully explaining the nature and objectives of the study, written informed consent will be obtained from each patient of study group.
Participants belonging to both study groups would receive conventional periodontal treatment, i.e. scaling and root planing (SRP).
Clinical measurement
All of the participants will undergo full mouth examination in a standardized way using illumination by a standard dental light, a mouth mirror, explorer and University of North Carolina -15(UNC-15) periodontal probe and the following parameters will be recorded: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL). Degree of maxillary incisor coverage by upper lip at rest would be classified into 2 types: total coverage, maxillary labial gingiva exposed. Teeth will be assessed at four sites for PI and GI, and at six sites for PD, CAL, and BOP during full mouth periodontal examination. BOP will be assessed as a dichotomous measure within 15 seconds of probing to full pocket depth. After the initial readings for PI, GI, BOP, PD, CAL at baseline will be recorded; patients would receive oral hygiene instructions and full-mouth SRP. Patients will be re-examined at 4th, 8th, 12th week. Reinforcement of oral hygiene will be carried out at each recall visit. PI, BOP and GI will be recorded at 4, 8 and 12 weeks of treatment. The other parameters would be measured only at the completion of 12 weeks of SRP.
All clinical periodontal examinations will be carried out by a single investigator to preclude any inter-examiner variability.
- Conditions
- Chronic Periodontitis
- Being tested
- SRP
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRPProcedure or surgery
patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing (SRP) Receives: Procedure: SRP |
| Control Group | Active comparator | Nose breathers having chronic periodontitis will receive scaling and root planing (SRP) Receives: Procedure: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOP (Bleeding on probing)
Bleeding on probing Bleeding on probing (BOP) has been used to clinically characterize the degree of gingival /periodontal inflammation.
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 posted30 May 2017
- Study start14 Oct 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manpreet Kaur, Principal investigator, Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169322
- Sponsor's protocol ID
- Manpreet Perio
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mouth Breathing on Outcome of Scaling and Root Planing in Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03169322
- Acronym / sponsor ID
- Manpreet Perio
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 May 2017 (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.
Studies reveal association between dry conditions and decreased healing in wounds or any treatment. From these studies, it can be hypothesized that healing in mouth breathers after scaling and root planing in terms of bleeding on probing, gingival index, plaque Index, clinical attachment level, probing depth may not show as much improvement as in case of nose breathers. No study has been conducted till date to find effect of scaling and root planing in periodontitis patients among mouth breathers and nose breathers.
Detailed description
INTRODUCTION
Mouth breathing is perceived to be responsible for persistant marginal gingivitis. The most common region to be affected by gingivitis in mouth breathers is maxillary anterior region. Other areas are affected in following decreasing order: maxillary posterior areas, mandibular anterior region and mandibular posterior region. Various reasons are considered to be responsible for gingival inflammation in mouth breathers. Possible factors responsible for gingival inflammation may be continuous loss of saliva over marginal tissues leading to increased plaque scores or qualitative change in plaque in terms of incorporation of more virulent strains of bacteria in plaque.
Mouth breathing, lip seal, upper lip coverage are related. In one study, mouth breathing along with incompetent lip seal and decreased upper lip coverage were associated with gingivitis. In other study plaque was thought to be a contributing factor for gingivitis in patients with decreased upper lip coverage. One study showed lack of lip seal due to increased overjet to be responsible for increased gingival inflammation. Kolawole KA et al in their study found that lip incompetence was associated with increased plaque scores. It may be due to lack of normal cleansing action of saliva. No association between mouth breathing and gingivitis prevalence had been reported in the study by Sutcliffe. However mouth breathing slightly increased severity of gingivitis.
Saliva performs very important functions including lubrication of oral tissues, antimicrobial action, regulation of pH, elimination of food bolus and facilitating in removal of carbon. Salivary flow provides mechanical cleansing of residues present in mouth such as non adherent bacteria, cellular and food debris. Lack of salivary flushing action results in accumulation of food debris and dental plaque thus promoting an acidogenic and aciduric oral bacteria responsible for dental caries.
Xerostomia /dry mouth is responsible for increase in gingival inflammation and also affects periodontal conditions with increased probing depth, plaque index. In one study, young adults with self reporting of xerostomia had increased sites with bleeding on probing and increased plaque scores. Proliferative activity of oral gingival epithelium is decreased in inflamed gingiva of patients with xerostomia. In one study, healing in gingivectomy wound was delayed in sialadenectomized rats.
In habitual mouth-breathers, 50% of the inspired air passes through mouth. In mouth-breathers, amount of water evaporated from saliva into air may reach 0.24 mL/min resulting in greater retention of bacteria in oral cavity.
For transient relief of xerostomia, salivary substitutes and sugar free gums and lozenges are available. Effect of salivary substitutes along with scaling and root planing in mouth breathers have been evaluated in one study. It was found that in mouth breathers, scaling and root planing along with application of salivary substitutes provided better improvement in gingival index, bleeding on probing, clinical attachment level than in whom scaling and root planing alone was performed.
Better response of gingiva was seen in mouth breathers after 4-6 weeks of oral debridement and use of petroleum jelly. However when use of petroleum jelly was withheld inflammation was again noticed in gingiva.
Similar effects of drying conditions are seen in various parts of body. In children with dry skin and predisposition to atopic dermatitis, use of emollients was seen to improve their skin conditions.
All these studies reveal association between dry conditions and decreased healing in wounds or any treatment. From these studies, it can be hypothesized that healing in mouth breathers after scaling and root planing in terms of bleeding on probing, gingival index, plaque Index, clinical attachment level, probing depth may not show as much improvement as in case of nose breathers. No study has been conducted till date to find effect of scaling and root planing in periodontitis patients among mouth breathers and nose breathers.
MATERIAL AND METHODS
This study will be conducted in Department of Periodontics, Post Graduate Institute of Dental Sciences(PGIDS), Rohtak.
STUDY POPULATION AND DESIGN
Patients suffering from chronic periodontitis of age group 20-35 years will be recruited from regular OPD of the Department of Periodontics in the study. Approximately 60 patients would comprise test group and control group. Test group (n≈30) will include individuals having mouth breathing habit. Control group (n≈30) will comprise of patients who are nose breathers.
METHODOLOGY
The study will be conducted in accordance with the ethical standards outlined in the 1964 Declaration of Helsinki, as revised in 2013.
Diagnosis of mouth breathing
Diagnosis of mouth breathing will be made on the basis of patient history. Patients would be asked whether, in their opinion, they are mouth breathers, and also whether they have dry mouth on awakening.
Study groups
After carefully explaining the nature and objectives of the study, written informed consent will be obtained from each patient of study group.
Participants belonging to both study groups would receive conventional periodontal treatment, i.e. scaling and root planing (SRP).
Clinical measurement
All of the participants will undergo full mouth examination in a standardized way using illumination by a standard dental light, a mouth mirror, explorer and University of North Carolina -15(UNC-15) periodontal probe and the following parameters will be recorded: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL). Degree of maxillary incisor coverage by upper lip at rest would be classified into 2 types: total coverage, maxillary labial gingiva exposed. Teeth will be assessed at four sites for PI and GI, and at six sites for PD, CAL, and BOP during full mouth periodontal examination. BOP will be assessed as a dichotomous measure within 15 seconds of probing to full pocket depth. After the initial readings for PI, GI, BOP, PD, CAL at baseline will be recorded; patients would receive oral hygiene instructions and full-mouth SRP. Patients will be re-examined at 4th, 8th, 12th week. Reinforcement of oral hygiene will be carried out at each recall visit. PI, BOP and GI will be recorded at 4, 8 and 12 weeks of treatment. The other parameters would be measured only at the completion of 12 weeks of SRP.
All clinical periodontal examinations will be carried out by a single investigator to preclude any inter-examiner variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Procedure: SRPpatients having chronic periodontitis with mouth breathing habit will receive scaling and root planing (SRP) |
| Control Group | Active comparator | Procedure: SRPNose breathers having chronic periodontitis will receive scaling and root planing (SRP) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy individuals possessing ≥ 20 natural teeth.
- Chronic periodontitis criteria as defined by division of Oral Health at the Centre for Disease Control and Prevention(CDC) in collaboration with American Academy of Periodontology(AAP)-(Page and Eke 2012) i.e. at least two or more interproximal sites with clinical attachment loss(CAL) ≥ 4mm(not on same tooth), or ≥2 interproximal sites with Pocket Depth(PD) ≥5 mm(not on same tooth).
- BOP prevalence >25%.
Key exclusion criteria (8 listed)
- Patients on anti-inflammatory drugs or antibiotics within previous 6 months of commencement of study, or on any other regular medication or mouth wash, that is likely to influence periodontal status.
- History of periodontal treatment within 1 year of inclusion in the study.
- Current or former smokers or use of tobacco in any form.
- History of treatment with statins, glucocorticoids, anticoagulants, phenytoin, calcium channel blockers such as nifedipine, diltiazem, verapamil, felodipine; immunosuppressants such as cyclosporine; bisphosphonates or any other host modulatory drugs during last six months.
- Non-plaque-induced gingival lesions.
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 |
|---|---|---|
| SRPpatients having chronic periodontitis with mouth breathing habit will receive scaling and root planing | Procedure or surgery | Control Group, Test Group |
Primary outcome
BOP (Bleeding on probing)
Time frame: 12 Weeks
Bleeding on probing Bleeding on probing (BOP) has been used to clinically characterize the degree of gingival /periodontal inflammation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: Yes
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Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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Evaluation of Masticatory Performance in Patients With Periodontitis
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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.
Manpreet Kaur principal investigator
Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP in people with Chronic Periodontitis, 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 3 inclusion and 8 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 30 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tewari (01262283876, principalpgids@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOP (Bleeding on probing) (time frame: 12 Weeks). 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 30 May 2017.