Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:42 AM
Study NCT ID:
NCT07472218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Dressings in Non-Surgical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010514', 'term': 'Periodontal Pocket'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The primary investigator responsible for clinical data collection and sample procurement is masked to the treatment allocation. Specifically, the examiner performing the periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) and collecting the subgingival plaque samples at baseline, 1 month, and 3 months is blinded to which quadrants received the Ora-Aid or Coe-Pak dressings. To maintain this blinding, the dressings are removed by a separate clinician one week post-treatment, ensuring that the examining researcher has no knowledge of the intervention assigned to each split-mouth site during the follow-up evaluations.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week.\n\nPatients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Probing Pocket Depth (PPD)', 'timeFrame': 'Baseline, 1st and 3rd months', 'description': 'PPD will be measured at six sites per tooth using a calibrated periodontal probe. The mean value per patient will be calculated. A decrease in PPD indicates clinical improvement.\n\nUnit of Measure: Millimeters (mm)'}, {'measure': 'total bacterial load', 'timeFrame': 'baseline, 1 month, and 3 months', 'description': 'This study involves the longitudinal comparison of total bacterial load, assessed via plaque samples collected from the deepest periodontal pockets on both the right and left sides at baseline, 1 month, and 3 months post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Evoluation of Gingival Index (GI)', 'timeFrame': 'Baseline, 1st and 3rd months.', 'description': 'Gingival inflammation will be assessed using the Loe and Silness Gingival Index. Scores range from 0 to 3 (0 = Normal gingiva; 3 = Severe inflammation, ulceration, tendency to spontaneous bleeding).\n\nUnit of Measure: Units on a scale (Score 0-3)'}, {'measure': 'Plaque Index (PI) Scores', 'timeFrame': 'Baseline, 1 month, 3 months.', 'description': 'Oral hygiene status will be assessed using the Silness and Loe Plaque Index. Scores range from 0 to 3 (0 = No plaque; 3 = Abundance of soft matter).\n\nUnit of Measure: Units on a scale (Score 0-3)'}, {'measure': 'Percentage of Sites with Bleeding on Probing (BOP)', 'timeFrame': 'Baseline, 1 month, 3 months.', 'description': 'Presence or absence of bleeding will be recorded within 30 seconds after probing. The result will be expressed as the percentage of total sites that bleed.\n\nUnit of Measure: Percentage of sites (%)'}, {'measure': 'Change in Clinical Attachment Loss (CAL)', 'timeFrame': 'Baseline, 1 month, 3 months.', 'description': 'CAL is measured as the distance from the cemento-enamel junction to the bottom of the periodontal pocket. The mean value per patient will be recorded.\n\nUnit of Measure: Millimeters (mm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'Non-surgical periodontal therapy', 'Periodontal dressing', 'Ora-Aid', 'Coe-Pak', 'total bacterial load'], 'conditions': ['Periodontitis', 'Periodontitis (Stage 3)', 'Periodontal Pocket']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. The study utilizes a split-mouth design to analyze clinical periodontal parameters, patient comfort, and microbiological changes over a 3-month period.', 'detailedDescription': "Scope:\n\nTooth surface cleaning and root surface planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and tartar from diseased root surfaces. Periodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root surface planing cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.\n\nThe aim of this study is to analyze the clinical parameters, patient comfort, and microbiological benefits of different wound dressings used in dental calculus removal and root planing in the treatment of patients with periodontitis.\n\nTopic: Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life.\n\nScaling, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, in patients who participate in a regular maintenance program following scaling and root planing, less tooth loss and clinical attachment loss are observed. Scaling and root planing are an integral part of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces.\n\nPeriodontal wound dressings began to be used in the early 19th century to protect periodontal wounds. These wound dressings provide protection in the treated area and, by remaining in close contact with the tissue and tooth, help stabilize the clot and protect it from external and internal forces during function. It has also been reported that tooth surface cleaning and root planing procedures cause separation and structural damage in the lingual and buccal soft tissues. The use of periodontal dressings is recommended to improve the health of these damaged tissues and reduce patient discomfort.\n\nCoe-Pak is the most commonly used eugenol-free intraoral wound dressing. It consists of two pastes: the base paste contains zinc oxide with added oils and gums, and lorothidol, a fungicide related to hexachlorophene. The catalyst paste contains colophony resin or resin and coconut fatty acids thickened with chlorothymol as an antibacterial agent. Materials of equal length are placed on a waxed paper pad and mixed using a wooden spatula until a thick consistency and uniform color are achieved. The reaction time can be altered by adding a few drops of warm water during mixing or by dipping the package into a container of warm water immediately after mixing. When the paste loses its stickiness, it can be transferred to the patient's mouth using gloves moistened with water and placed in a thin layer over the affected teeth.\n\nOra-Aid is an eugenol-free dental wound dressing introduced for use by dentists in 2017 by TBM (Technological Bio-Materials). Developed as a hydrophilic polymer, Ora-Aid does not have adhesive strength when first opened, but reacts within 3-5 seconds when it comes into contact with oral fluid and forms a strong adhesive bond. Ora-Aid can be used for various purposes in dental clinics. It can be used after implants and tooth extractions, after periodontology procedures, for wounds in the mouth after orthodontics, and for other wounds in the mouth. When applied, it protects the area from food, bacteria, and cigarette smoke. It prevents secondary infections. It stops bleeding and significantly reduces the patient's pain. Ora-Aid is slowly absorbed in the mouth and is resorbed within a certain time depending on oral activity. Ora-Aid is a CE-certified product with a TUS registration. It consists of hydrophilic high polymer materials containing raw materials compliant with the Korean Pharmacopoeia and USP (US Patent) standards and vitamin E. There are no contraindications for its absorption and swallowing. Its mint aroma enhances the feeling of freshness in the mouth.\n\nThe aim of our study is to evaluate the patient comfort, effect on clinical periodontal parameters, and microbiological efficacy of periodontal wound covering materials used during non-surgical periodontal treatment in patients with periodontitis.\n\nMethod Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week.\n\nPatients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study if they voluntarily agree to participate. Patients who have used antibiotics in the last 3 months, patients who have undergone periodontal treatment in the last 6 months, patients with systemic diseases, patients who smoke, patients with pain, patients with interproximal caries, patients using orthodontic appliances and/or removable prostheses, and patients who are pregnant or breastfeeding will not be included in the study. Participants will be advised not to use any medications during the study period.\n\nAt baseline and at 1 and 3 months after treatment, patients' Gingival Indices⁶ (GI/ Loe and Silness Gingival index), Plaque Indices⁷ (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index), and Papillary Bleeding Indices⁸ (PBI/ Saxer et al.) and Bleeding on Probing Indexes9 (BOP), Probing Pocket Depth10 (SCD), and Clinical Attachment Loss11 (CAL) will be recorded. At the start of treatment and 1 month after treatment, plaque samples will be collected from the deepest pockets on the right and left sides, and the total bacterial load will be compared.\n\nClinical follow-ups to be performed by the physician\n\nClinical Records:\n\nThe patient's age, gender, and systemic diseases will be recorded. Upon the patient's first visit, all oral clinical indices will be taken, and plaque samples will be collected from the deepest pathological pockets.\n\nThe form used for diagnosis for every patient who comes to our clinic is provided in the attachment. The indices to be checked during the examination are listed below.\n\nGingival Index (GI, Löe \\& Silness, 1963, 1967) This index was developed by Löe and Silness in 1963 and modified by various researchers in 1967. In this system, bleeding, the most fundamental sign of inflammation, is evaluated. The mesial, distal, vestibular, and lingual gingivae of the teeth are evaluated. These values are then added together and divided by four. This is how the gingival index is calculated. Dividing the sum of the values by the number of teeth gives the individual's score.\n\nGingival Index Values\n\n1. 0 Healthy gums, no inflammation.\n2. 1 Mild inflammation, discoloration, and slight edema in the gums, no bleeding on probing.\n3. 2 Moderate inflammation, redness, and edema in the gums, bleeding on probing.\n4. 3 Severe inflammation, redness, and edema in the gums, spontaneous bleeding is observed.\n\nPapilla Bleeding Index (PBI, Saxer \\& Mühleman, 1975) Bleeding in the gingival papilla is assessed by probing. Probing is performed on 4 half-jaws. However, to ensure that the assessment reflects the inflammation of all papillae and to facilitate the procedure, the assessment is performed on the papillae on the facial surfaces of the teeth in the right upper and left lower jaws on the oral side, and in the left upper and right lower jaws on the buccal side. The values found are then divided by the total number of papillae to find the average papillary bleeding index value. This index is very important in terms of patient motivation. Patients who see bleeding in their gums can easily identify the diseased area in their mouth and develop positive behaviors in applying the oral care procedures they have been taught.\n\nPapillary Bleeding Index Values\n\n1. 0 No bleeding.\n2. 1 There is slight bleeding 20 seconds after probing.\n3. 2 There is linear bleeding in the papilla area after probing.\n4. 3 There is bleeding that fills the interdental area after probing.\n5. 4 Excessive bleeding overflowing from the interdental area after probing. Plaque Index(PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index) Investigates the amount of plaque on the facial and lingual surfaces using a plaque-disclosing agent. The total score is divided by the number of surfaces examined, and the index score for the individual is determined.\n\nThe plaque-disclosing agent (Tri Plaque ID GelTM, GC Dental, USA) is applied to all tooth surfaces using a fine-tipped brush.\n\nAreas on the tooth surfaces stained pink, purple, or blue are scored from 0 to 5 (Score 0: no plaque, 1: isolated plaque patches at the gingival margin, 2: plaque in a thin band at the gingival margin, 3: plaque covering less than 1/3 of the tooth surface, 4: plaque covering no more than 2/3 of the tooth surface, 5: plaque covering more than 2/3 of the tooth surface). The entire mouth is divided into 6 different areas, and the average TQHPI values of the participants are calculated by taking the mathematical ratio of the values obtained from the mesial, distal, lingual, and vestibular surfaces of specific teeth in each sextant.\n\nBleeding on Probing Index ( Ainamo \\& Bay, 1976) In this index, probing and bleeding are evaluated by gently probing the pocket. The evaluation is based on the presence or absence of bleeding in the gums as a result of probing. If bleeding occurs within 10-15 seconds after probing all teeth in the mesial, distal, vestibular, and lingual gingival sections, a positive value is given. The ratio of the bleeding area to the examined area is expressed as a percentage.\n\nProbable pocket depth Probable pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket base using a standard periodontal probe with a tip diameter of approximately 0.4-0.5 mm and rounding to the nearest mm.16 Clinical Attachment Loss (CAL): This is the value obtained by measuring the distance between the pocket base and the enamel-cementum junction using a standard periodontal probe with a diameter of 0.4-0.5 mm and rounding it to the nearest mm.\n\nPostoperative records Clinical indices will be taken before periodontal treatment, at 1 month, and at 3 months.\n\nForm Appendix -D has been created for clinical follow-ups to be performed by the physician.\n\nMicrobiological examination:\n\nPlaque samples taken from each patient for microorganism quantification will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis.\n\nPlaque samples stored at -80°C in Eppendorf tubes will be transported in dry ice thermal storage bags by personal vehicle to the laboratories of Kırklareli University Faculty of Medicine, where microbiological examination will be performed.\n\nDNA isolation will be performed from all suture samples using High Pure PCR Template (Roche Diagnostics GmBH, Mannheim, Germany) according to the manufacturer's instructions. DNA will be stored at 80°C until the process is completed.\n\nThe 16S rRNA gene will be detected by qPCR, and the total amount of bacteria will be determined. The 16S rRNA gene will be amplified using primers specific to the 16S rRNA gene: 50-TCCTACGGGAGCACAGT-30 and 50-GGACTACCAGG GTATCTAATCCTG T-30. To establish a standard curve for quantification, 16S-specific plasmids with known values will be obtained from Bioeksen (Istanbul, Turkey). Real-time PCR procedures will be performed on the LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit (Roche Diagnostics, Mannheim, Germany) according to the manufacturer's instructions. The analysis will be performed in a total volume of 20 mL with 5 mL of template DNA and 15 mL of master mix. The real-time PCR (qPCR) protocol will consist of enzyme activation at 95°C for 10 minutes; 40 PCR cycles (single read) at 95°C for 20 seconds, 60°C for 20 seconds, and 72°C for 15 seconds; and 10 seconds at 95°C, followed by 1 minute at 65°C for melting curve analysis, and continuous reading at 95°C."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systemically healthy volunteers aged 18-45 years.\n2. Diagnosis of Periodontitis (Stage 3, Grade A).\n3. Presence of at least 20 permanent teeth.\n4. Capacity to understand the study protocol and provide informed consent.\n\nExclusion Criteria:\n\n1. Systemic diseases (e.g., Diabetes, Chronic Renal Failure, Cancer, Connective Tissue Disorders).\n2. Pregnancy or breastfeeding.\n3. Smoking (\\>10 cigarettes/day).\n4. Antibiotic use within the last 3 months or periodontal treatment within the last year.\n5. Presence of orthodontic appliances, removable prostheses, or extensive interproximal caries.'}, 'identificationModule': {'nctId': 'NCT07472218', 'briefTitle': 'Periodontal Dressings in Non-Surgical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Comparison of the Effectiveness of Two Different Periodontal Wound Dressings in Non-Surgical Periodontal Therapy', 'orgStudyIdInfo': {'id': 'Seval 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ora-aid side', 'description': "A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week.", 'interventionNames': ['Procedure: Coe-Pack application']}, {'type': 'EXPERIMENTAL', 'label': 'Coe-pack side', 'description': "A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week.", 'interventionNames': ['Procedure: Ora Aid application']}], 'interventions': [{'name': 'Ora Aid application', 'type': 'PROCEDURE', 'description': 'Baseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis.\n\nIntervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants.\n\n1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites.\n\n1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR.\n\n3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains.', 'armGroupLabels': ['Coe-pack side']}, {'name': 'Coe-Pack application', 'type': 'PROCEDURE', 'description': 'Baseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis.\n\nIntervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants.\n\n1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites.\n\n1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR.\n\n3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains', 'armGroupLabels': ['Ora-aid side']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SEVAL CEYLAN ŞEN, Assist Prof', 'role': 'CONTACT', 'email': 'dt.sceylan@hotmail.com', 'phone': '+905333161232'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A decision has not yet been made regarding the sharing of individual participant data. The decision will be finalized upon the completion of the study and publication of the primary results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'SEVAL CEYLAN ŞEN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}