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Investigating the effect of gel containing chitosan in grade II furcation involvement defects

Clinical and radiographic investigation of the effect of gel containing chitosan in grade II furcation involvement defects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211221053471N1
Enrollment
44
Registered
2023-12-23
Start date
2023-12-22
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

grade II furcation involvement defects. Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention 1: Intervention group: A gel containing chitosan is randomly placed in each of the samples. Intervention 2: Control group: Chitosan-free gel is randomly placed in each sample.

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients with moderate to severe chronic periodontitis with grade II furcation involvement on the lingual or buccal side of the first or second molar of the lower jaw and need treatment. .Index plaque before surgery should be less than 20% The horizontal probe depth (Horizontal Probe Depth, HPD) in the involved areas is greater than or equal to 3.

Exclusion criteria

Exclusion criteria: Having a systemic disease Need for prophylactic antibiotics to prevent bacterial endocarditis Use of medications that interfere with periodontal healing smoking Presence of contraindications for periodontal surgery Teeth with anatomical complications such as CEP, bifurcation ridge, accessory canal and concavity More tooth mobility than class II Presence of decay and repair in the furcation area Presence of evidence of periapical pathology in the clinical or radiographic appearance of the tooth in question The possibility of the patient's lack of acceptable cooperation after the initial periodontal treatment Having a history of coagulation problems

Design outcomes

Primary

MeasureTime frame
(Vertical probing depth) VPD: means the distance between the margin of the gum to the point where the gum epithelium adheres to the surface of the tooth, which is measured by the probe. To measure the depth of the pocket, the calibrated periodontal probe is inserted from the facial, lingual, mesial and distal surfaces of the tooth so that the tip of the probe is parallel to the longitudinal axis of the tooth, enters the gingival sulcus and the depth of the pocket is measured. The numbers obtained in the file related to Each patient is registered. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.;(Vertical clinical attachment level) VCAL: First, the CEJ of the desired tooth is determined by a probe, the distance from the edge of the margin to this area is recor

Secondary

MeasureTime frame
Gingival recession: if the gingival margin is below the CEJ, we consider its existence as positive, and if the gingival margin is above the CEJ, this parameter is recorded as absent. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged.;Gingival Index: based on the percentage of tooth surfaces. which has inflammation, determines the severity and existence of gingivitis. and Subtraction Radiography based on the formation or lack of bone formation in the parallel periapical. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParastoo Madieh

Babol University of Medical Sciences

parastoomadieh@gmail.com+98 991 151 0075

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026