Clinical trial NCT06727929: The Effect of Non-surgical Periodontal Treatment on Dickkoff-1 and Secreted Frizzled Related Protein-5 Levels
Official title: The Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Dickkoff-1(Dkk-1) and Secreted Frizzled Related Protein 5 (sFRP5) Levels
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Periodontal Inflammation
Alveolar Bone Loss
Periodontal Diseases
Keywords: Dickkopf-1
secreted Frizzled Related Protein 5
Gingival crevicular fluid
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
Collaborators: name: Kırıkkale University
First posted: 2024-12-11
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 99 patients (44 males and 55 females) between 20-50 years of age were included and were divided into three groups as follows: periodontally healthy, patients with gingivitis, and patients with stage 3 grade B periodontitis. Participants were selected from the patients who presented for periodontal treatment between March 2024 and August 2024 at Department of Periodontology, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.

Brief summary: Periodontitis is a condition that is defined by microbial-associated, host-induced inflammation, which ultimately results in the loss of periodontal attachment.Periodontal clinical parameters are the most reliable indicators of periodontal disease; however, they provide information about past tissue destruction and are insufficient for predicting future periodontal disease activity. Therefore, evaluation of Dickkopf-1 (Dkk-1) and secreted Frizzled related protein 5 (sFRP5), which are Wnt signaling pathway antagonists, in periodontal inflammation may be a focus of interest. A total of 99 individuals, 44 male and 55 female, participated in our study and were divided into three groups as periodontally healthy, gingivitis and periodontitis. Non-surgical periodontal treatment was applied to the disease groups. Dkk-1 and sFRP5 were evaluated in gingival crevicular fluid (GCF) at the baseline and after periodontal treatment.

Detailed description: The participants were divided into three groups in accordance with their periodontal status according to the 2017 World Workshop on the classification of periodontal diseases : Periodontally healthy (group H, n = 33, probing depth (PD) ≤3 mm, fullmouth bleeding scores; bleeding on probing (BOP) % \<10, no clinical attachment levels (CAL) and radiologic bone loss), gingivitis (group G, n = 33 PD ≤3 mm, % BOP \>30, no CAL(due to periodontal disease) and radiologic bone loss), Stage 3 Grade B periodontitis (group P, n = 33, These individuals had a minimum of two non-adjacent teeth with sites with PD ≥6 mm, CAL ≥5 mm, BOP ≥30%, tooth loss due to periodontitis ≤4 teeth, the alveolar bone loss at radiographs extending to middle or apical third of the root, the presence of consistent amounts of plaque biofilm/calculus deposits commensurate with the severity of periodontal tissue breakdown, the proportion of percentage bone loss to age values were between 0.25 and 1). Panoromic and periapical radiographic examination was also performed for the diagnosis of periodontitis.

Periodontal status of each individual included in the study was determined by measuring plaque index (PI), gingival index (GI), PD, clinical attachment level (CAL) and bleeding of probing (BOP). PD and CAL were measured on six sites (mesio-buccal/ facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) of the teeth in baseline and after periodontal treatment. Bleeding was observed up to 10 sec after the examination of probing depth and BOP score was calculated as the number of BOP-positive sites was divided the number of total sites, after multiplied with 100. Panoramic and periapical radiographs were used to determine the alveolar bone loss. All clinical measurements were recorded using a standard Williams periodontal probe.

Within 2 weeks from the screening visit, phase 1 periodontal treatment/scaling and root planing under local anesthesia using manual instruments and ultrasonic devices in a single appointment were performed and oral hygiene instructions were given to all participants with periodontitis by a single calibrated periodontist. In gingivitis and periodontally healthy groups, phase 1 periodontal treatment and oral hygiene education were given to each one. All periodontal clinical measurements recorded and gingival crevicular fluid (GCF) samples collection were at baseline and the 6-8 th week after the periodontal treatment in patients with G and P group and at one time point (baseline) in H group.

Eligibility criteria: Inclusion Criteria:

* Being between 20-50 years old
* Meeting the criteria for the working groups

Exclusion Criteria:

* having any systemic or metabolic diseases or insturition of effected bone metabolism,
* having bruksizm habits,
* pregnant or lactating,
* received periodontal/peri-implant treatment within the last 6 months,
* the history of antibiotics or antiinflamatuars use regularly within the last 6 months,
* having \< 20 teeth (except for 3rd molars),
* smokers or consumed alcohol.

Primary outcomes:
measure: Dkk-1 and sFRP5 levels at baseline and after periodontal treatment
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Gingival Crevicular Fluid (GCF)Volume at baseline and after periodontal treatment
timeFrame: 6-8 weeks
measure: Gingival index (GI) at baseline and after periodontal treatment
timeFrame: 6-8 weeks
measure: Bleeding on probing (BOP) percentage at baseline and after periodontal treatment
timeFrame: 6-8 weeks
measure: Probing depth (PD)at baseline and after periodontal treatment
timeFrame: 6-8 weeks
measure: Plaque index (PI) at baseline and after periodontal treatment
timeFrame: 6-8 weeks
measure: Clinical attachment levels (CAL) at baseline and after periodontal treatment
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University
name: Şükran Acıpınar
role: PRINCIPAL_INVESTIGATOR
References: