The Impact of Cigarette Smoking on Periodontal Therapy

NCT05120206 | Completed

• 1 other identifier: 94605
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study. Data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy. Data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival crevicular fluid.

Conditions

Periodontitis; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• PD ≥5 mm with BoP

  Corrected for clustering within patients, teeth, and sites over time, was the unit of the analysis and PD ≥5 mm with BoP was the outcome (dependent variable) dichotomized as present (1) or absent (0).

  24 months

Secondary Outcomes (10)

• Teeth present

  24 months

• Clinical periodontal attachmentloss

  24 months

• Periodontal pocket depth

  24 months

• Bleeding at site level

  24 months

• Bleeding at patient level

  24 months

Study Arms (2)

Cigarette smokers with periodontitis

ACTIVE COMPARATOR

Periodontal therapy in cigarette smokers

Procedure: Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).

Non-smokers with periodontitis

ACTIVE COMPARATOR

Periodontal therapy in non-smokers

Procedure: Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).

Interventions

Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA). PROCEDURE

Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers

Also known as: Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).

Cigarette smokers with periodontitis; Non-smokers with periodontitis

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects
• age 35-75 years
• diagnosed with chronic periodontitis
• at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
• either smokers (\>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).

You may not qualify if:

• subjects who presented with any current medical condition or used medications known to affect periodontal healing
• incorrectly reported smoking status
• use of antibiotics within 6 months of the study
• received subgingival scaling within 6 months of the study

Sponsors & Collaborators

• University of Bergen: lead

Related Publications (2)

• Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.

  PMID: 26407817 RESULT

• Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.

  PMID: 28306142 RESULT

MeSH Terms

Conditions

Periodontitis; Cigarette Smoking

Interventions

Educational Status; Oral Hygiene; Gingivectomy; chlorhexidine gluconate; Chlorhexidine; halofantrine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Hygiene; Therapeutics; Preventive Dentistry; Dentistry; Oral Surgical Procedures; Surgical Procedures, Operative; Periodontics; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dagmar F. Bunæs, PhD

  Department of Clinical Dentistry - periodontics, University of Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 15, 2021
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share