Periodontitis (Stage 3)
Conditions
Keywords
periodontal debridement, Erbium; Laser therapy, RANK ligand, Sclerostin, Osteoprotegerin, smoking
Brief summary
Periodontitis is an inflammatory disease that affects the tissues supporting the teeth. If the disease progresses, it can cause loss of the tissues and bone around the teeth and lead to the formation of deep spaces, called periodontal pockets, between the teeth and gums. The main treatment for periodontitis is to improve oral hygiene and remove bacterial deposits and calculus from the tooth and root surfaces. Smoking is an important risk factor for periodontitis and may reduce the response to periodontal treatment by negatively affecting tissue healing. For this reason, additional treatments that may improve healing in smokers are being investigated. One of these approaches is the use of dental lasers together with conventional nonsurgical periodontal treatment. The purpose of this study is to investigate whether adding Er,Cr:YSGG laser treatment to nonsurgical periodontal therapy improves treatment outcomes in systemically healthy smokers with Stage III periodontitis. This study will use a split-mouth design, meaning that two different treatments will be compared within the same participant. One side of the mouth will receive conventional nonsurgical periodontal treatment, including scaling and root surface instrumentation. The other side will receive the same treatment together with Er,Cr:YSGG laser application. Changes in gum health, periodontal pocket depth, bone-related findings on radiographs, and biological markers related to bone metabolism will be evaluated during follow-up. The study hypothesis is that adding Er,Cr:YSGG laser treatment to conventional nonsurgical periodontal therapy will provide additional clinical, radiographic, and biochemical benefits compared with conventional nonsurgical periodontal therapy alone in smokers with Stage III periodontitis.
Detailed description
Periodontitis is a chronic multifactorial inflammatory disease associated with dental biofilm and characterized by progressive destruction of the tooth-supporting tissues, including clinical attachment loss and alveolar bone loss. Smoking is an important modifiable risk factor for periodontitis and may adversely affect the host inflammatory response, periodontal wound healing, and bone metabolism. In the 2017 classification of periodontal diseases, smoking is considered an important modifier in determining the grade of periodontitis. Non-surgical periodontal therapy is the first-line approach for controlling periodontal inflammation through disruption and removal of subgingival biofilm and calculus. However, complete instrumentation may be difficult in deep periodontal pockets and anatomically complex areas. These limitations have led to the investigation of adjunctive treatment approaches that may enhance the clinical and biological response to conventional non-surgical periodontal therapy. Erbium lasers have been investigated as adjunctive tools in periodontal treatment because of their interaction with water-containing soft and hard tissues and their ability to ablate periodontal tissues and calculus with limited thermal damage when appropriate parameters are used. The Er,Cr:YSGG laser may provide additional effects through pocket decontamination, removal of diseased pocket epithelium and granulation tissue, root surface treatment, and modulation of the local healing environment. Periodontal treatment response may also be evaluated using biological markers associated with bone remodeling. Receptor activator of nuclear factor-kappa B ligand (RANKL) promotes osteoclast differentiation and bone resorption, whereas osteoprotegerin (OPG) acts as a decoy receptor for RANKL and inhibits osteoclast activation. Sclerostin is an osteocyte-derived protein involved in the regulation of bone formation. Assessment of these biomarkers in gingival crevicular fluid may provide additional information regarding the biological response to periodontal treatment. In addition, radiographic fractal analysis may provide a quantitative assessment of trabecular bone architecture that may not be reflected by conventional linear bone measurements. This randomized split-mouth clinical trial evaluates the adjunctive effect of Er,Cr:YSGG laser therapy in smokers with Stage III Grade C periodontitis. Contralateral regions are selected as test and control sites to reduce the influence of interindividual factors such as smoking exposure, host response, and oral hygiene behavior. Both sides receive non-surgical periodontal therapy, while the test side additionally receives Er,Cr:YSGG laser treatment according to a standardized periodontal protocol. Treatment response is assessed using clinical periodontal measurements together with gingival crevicular fluid biomarkers and standardized radiographic analyses during follow-up. The combined evaluation of clinical, biochemical, and radiographic changes is intended to provide a multidimensional assessment of the possible adjunctive effects of Er,Cr:YSGG laser therapy in a high-risk periodontal population. The aim of this randomized split-mouth clinical trial is to evaluate the adjunctive effects of Er,Cr:YSGG laser therapy on clinical periodontal parameters, gingival crevicular fluid biomarkers related to bone metabolism, and radiographic bone changes in smokers with Stage III Grade C periodontitis receiving non-surgical periodontal therapy. The study hypothesis is that adjunctive Er,Cr:YSGG laser therapy will produce differences in clinical, biochemical, and radiographic outcomes compared with non-surgical periodontal therapy alone.
Interventions
PROCEDURENonsurgical Periodontal Therapy
Nonsurgical periodontal therapy will consist of oral hygiene instructions followed by supra- and subgingival scaling and root surface instrumentation. Periodontal instrumentation will be performed using ultrasonic and hand instruments as required until the root surfaces are considered adequately debrided. No adjunctive laser treatment will be applied to sites allocated to the control side.
PROCEDURENonsurgical Periodontal Therapy + Er,Cr:YSGG Laser
Following nonsurgical periodontal therapy, sites allocated to the experimental side will receive adjunctive Er,Cr laser treatment. The laser will be applied into the periodontal pockets according to a standardized protocol using predefined laser parameters and an appropriate periodontal tip. Laser irradiation will be performed along the treated periodontal pocket sites as an adjunct to conventional scaling and root surface instrumentation.
Sponsors
Okan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to treatment allocation. The clinician performing the Er,Cr laser application cannot be blinded because of the nature of the intervention. Participants may also be aware of the laser application. Clinical, radiographic, and biochemical outcome assessments will be performed without knowledge of which side received adjunctive laser treatment.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 35 and 65 years * Systemically healthy status * Smoking ≥10 cigarettes/day for at least 5 years * Diagnosis of Stage III Grade C periodontitis according to the 2017 classification * Stage III classification based on periodontal tissue destruction, with interdental clinical attachment loss ≥5 mm * Presence of contralateral study sites suitable for split-mouth allocation, with clinical attachment loss ≥5 mm at both test and control sites * Presence of contralateral interdental regions between premolar teeth, without tooth loss, suitable for split-mouth allocation * No antibiotic use within the previous 3 months * No periodontal treatment within the previous 6 months
Exclusion criteria
* Systemic disease or condition affecting periodontal status, wound healing, or bone metabolism * Pregnancy or lactation * Non-smoker or smoking \<10 cigarettes/day * Gingivitis * Stage I, Stage II, or Stage IV periodontitis * Grade A or Grade B periodontitis * No suitable contralateral study sites for split-mouth allocation, defined as CAL ≥5 mm and PPD ≥5 mm at both test and control sites * Tooth loss in the selected interdental regions between premolar teeth planned for test or control allocation * Antibiotic use within the previous 3 months * Periodontal therapy within the previous 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level | Baseline, 6 weeks, 3 months, 6 months, 9 months, and 12 months | Clinical attachment level was measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. Higher values indicate greater periodontal attachment loss. A reduction in clinical attachment level from baseline indicates clinical attachment gain and periodontal improvement. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Probing Pocket Depth | Baseline, 6 weeks, 3 months, 6 months, 9 months, and 12 months |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORGokce Aykol Sahin, PhD
Okan University
Outcome results
None listed