Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06383455
Other study ID # Observational
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2018
Est. completion date March 1, 2019

Study information

Verified date April 2024
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is: - Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease? Researchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method.


Description:

The present study aims to compare the changes in clinical parameters and subgingival periodontopathogen rates (P. gingivalis, A. actinomycetemcomitans, T. forsythia, F. nucleatum, P. intermedia, T. denticola, P. micra, C. rectus, E. nodatum, Capnocytophaga spp, and E. corrodens) following full-mouth scaling and root planing procedures in participants with and without smoking habits.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria: - Having 15 or more permanent teeth (except third molars and teeth with endodontic lesions), - Having been diagnosed with generalized Stage III or IV periodontitis that progresses with periodontal support tissue loss in more than 30% of the teeth, - Having at least five teeth with probing depth(PD) =6mm, clinical attachment level(CAL) =5mm, and radiographic bone loss that extends to at least the middle of the root, - Having at least one tooth that meets the same PD and CAL criteria per quadrant. Exclusion Criteria: - Pregnancy or lactation, - Any systemic disease with a potential influence on the immune response (diabetes mellitus, bone metabolic diseases, immunosuppressive therapy, radiation etc.), - Existence of decay, restoration, or prosthesis on the sampling site, - Use of the anti-inflammatory drug and antibiotic within the last 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Non-surgical periodontal therapy
An ultrasonic device (Cavitron Plus, Dentsply®, Duisburg, Germany) and periodontal hand instruments (periodontal curettes; Chicago, IL) were used for non-surgical periodontal treatment. The treatment procedure also included detailed oral hygiene instructions and full-mouth scaling and root planing. Scaling and root planing (SRP) was applied to all four quadrants under local anesthesia in a single appointment. No medication or mouthwash was prescribed to the patients.

Locations

Country Name City State
Turkey Trakya University Edirne

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Darby IB, Hodge PJ, Riggio MP, Kinane DF. Clinical and microbiological effect of scaling and root planing in smoker and non-smoker chronic and aggressive periodontitis patients. J Clin Periodontol. 2005 Feb;32(2):200-6. doi: 10.1111/j.1600-051X.2005.00644.x. — View Citation

Grossi SG, Zambon J, Machtei EE, Schifferle R, Andreana S, Genco RJ, Cummins D, Harrap G. Effects of smoking and smoking cessation on healing after mechanical periodontal therapy. J Am Dent Assoc. 1997 May;128(5):599-607. doi: 10.14219/jada.archive.1997.0259. — View Citation

Haffajee AD, Yaskell T, Torresyap G, Teles R, Socransky SS. Comparison between polymerase chain reaction-based and checkerboard DNA hybridization techniques for microbial assessment of subgingival plaque samples. J Clin Periodontol. 2009 Aug;36(8):642-9. doi: 10.1111/j.1600-051X.2009.01434.x. Epub 2009 Jun 26. — View Citation

Kubota M, Tanno-Nakanishi M, Yamada S, Okuda K, Ishihara K. Effect of smoking on subgingival microflora of patients with periodontitis in Japan. BMC Oral Health. 2011 Jan 5;11:1. doi: 10.1186/1472-6831-11-1. — View Citation

Labriola A, Needleman I, Moles DR. Systematic review of the effect of smoking on nonsurgical periodontal therapy. Periodontol 2000. 2005;37:124-37. doi: 10.1111/j.1600-0757.2004.03793.x. No abstract available. — View Citation

Van der Velden U, Varoufaki A, Hutter JW, Xu L, Timmerman MF, Van Winkelhoff AJ, Loos BG. Effect of smoking and periodontal treatment on the subgingival microflora. J Clin Periodontol. 2003 Jul;30(7):603-10. doi: 10.1034/j.1600-051x.2003.00080.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis The baseline levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia, F. nucleatum, P. intermedia, T. denticola, P. micra, C. rectus, E. nodatum, Capnocytophaga spp, and E. corrodens), post-treatment levels, and elimination levels with treatment were evaluated using multiplex polymerase chain reaction (PCR) analysis.The observed rates of microorganisms were assessed by determining six main levels.
0: No colouring (<1% no bacteria)
Very light-colored staining (Determination of bacteria from 1% to 20%).
Light colored staining (Determination of bacteria from 21% to 40%),
Moderate colored staining (Determination of bacteria from 41% to 60%),
Dark colored staining (Determination of bacteria from 61% to 80%),
Very dark-colored staining (Determination of bacteria from 81% to 100%).
Baseline and four weeks after the periodontal therapy.
Secondary Change in clinical attachment level (CAL) CAL is the main clinical parameter indicating the severity of periodontal disease. CAL measurements were performed on six different surfaces of each tooth (disto-buccal/labial, mid-buccal/labial, mesio-buccal/labial, disto-lingual, mid-lingual, and mesio lingual) by using a periodontal probe (Williams probe; Chicago, IL) and average value was calculated in millimeters.
CAL 1-2 mm: Stage 1 periodontitis CAL 3-4 mm: Stage 2 periodontitis CAL = 5 mm: Stage 3/4 periodontitis
Baseline and 4 weeks after periodontal therapy
Secondary Change in probing depth (PD) PD is one of the clinical parameters indicating the severity of periodontal disease. PD measurements were performed on six different surfaces of each tooth (disto-buccal/labial, mid-buccal/labial, mesio-buccal/labial, disto-lingual, mid-lingual, and mesio lingual) by using a periodontal probe (Williams probe; Chicago, IL) and average value was calculated in millimeters.
PD = 4 mm: Stage 1 periodontitis PD = 5 mm: Stage 2 periodontitis PD = 6 mm: Stage 3/4 periodontitis
Baseline and 4 weeks after periodontal therapy
Secondary Change in gingival index (GI) scores GI is a clinical parameter indicating the severity of gingival inflammation. GI scores were noted for four different surfaces of each tooth (buccal, distal, mesial and lingual) and average value was calculated.
0 = normal gingiva;
= mild inflammation: slight change in color, slight edema, no bleeding on probing;
= moderate inflammation: redness, edema, and glazing, or bleeding on probing;
= severe inflammation: marked redness and edema, tendency toward spontaneous bleeding.
Baseline and 4 weeks after periodontal therapy
Secondary Change in plaque index (PI) scores PI is a clinical parameter indicating the severity of dental plaque accumulation and oral hygiene habits of individuals. PI scores were noted for four different surfaces of each tooth (buccal, distal, mesial and lingual) and average value was calculated.
0 = No plaque
= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Baseline and 4 weeks after periodontal therapy
Secondary Change in Bleeding on Probing (BOP) BOP is one the clinical parameters indicating the severity of gingival inflammation. BOP were noted as positive or negative for four different surfaces of each tooth (buccal, distal, mesial and lingual) and average positive value was calculated in %. Baseline and 4 weeks after periodontal therapy
See also
  Status Clinical Trial Phase
Completed NCT04712630 - Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft N/A
Completed NCT06127069 - Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device N/A
Completed NCT04964167 - Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis Phase 4
Completed NCT05906797 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis. N/A
Recruiting NCT03997552 - NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration N/A
Completed NCT05530252 - Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis Phase 4
Completed NCT04881357 - Antiplaque/Antigingivitis Effect of Lacer Oros Integral N/A
Recruiting NCT03790605 - A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis Phase 3
Enrolling by invitation NCT04971174 - Outcomes of Periodontal Regenerative Treatment
Not yet recruiting NCT05568290 - Interleukin-38 Levels in Individuals With Periodontitis
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Recruiting NCT03997578 - Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Enrolling by invitation NCT04956211 - Periodontal Treatment and Ischemic Stroke N/A
Recruiting NCT05971706 - Ozone Application in Periodontal Treatment N/A
Recruiting NCT06099574 - A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Active, not recruiting NCT05311657 - Oral Health and Severe COPD
Not yet recruiting NCT06453278 - (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
Not yet recruiting NCT05643287 - The Effect of Time on the Outcome of Periodontal Treatment. N/A