Influence of Mouth Breathing on Periodontal Healing
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SRP
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- 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.
Sites / Locations
- Post Graduate Institute of Dental SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Group
Control Group
Arm Description
patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing (SRP)
Nose breathers having chronic periodontitis will receive scaling and root planing (SRP)
Outcomes
Primary Outcome Measures
BOP (Bleeding on probing)
Bleeding on probing Bleeding on probing (BOP) has been used to clinically characterize the degree of gingival /periodontal inflammation.
Secondary Outcome Measures
Full Information
NCT ID
NCT03169322
First Posted
May 25, 2017
Last Updated
May 25, 2017
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03169322
Brief Title
Influence of Mouth Breathing on Periodontal Healing
Official Title
Influence of Mouth Breathing on Outcome of Scaling and Root Planing in Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing (SRP)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Nose breathers having chronic periodontitis will receive scaling and root planing (SRP)
Intervention Type
Procedure
Intervention Name(s)
SRP
Intervention Description
patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing
Primary Outcome Measure Information:
Title
BOP (Bleeding on probing)
Description
Bleeding on probing Bleeding on probing (BOP) has been used to clinically characterize the degree of gingival /periodontal inflammation.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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%.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tewari
Phone
01262283876
Email
principalpgids@yahoo.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manpreet Kaur
Organizational Affiliation
Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tewari
Phone
01262283876
Email
principalpgids@yahoo.in
First Name & Middle Initial & Last Name & Degree
Manpreet Kaur
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Influence of Mouth Breathing on Periodontal Healing
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