Impact of Supracrestal Tissue Attachment Dimension on Outcome of Scaling and Root Planing and Open Flap Debridement Procedure in Different Periodontal Phenotypes
"Impact of Supracrestal Tissue Attachment Dimension on the Outcome of Scaling and Root Planing and Open Flap Debridement Procedure in Patients With Stage II and Stage III Periodontitis in Thin Versus Thick Periodontal Phenotype: A Comparative Interventional Study"
1 other identifier
interventional
48
1 country
1
Brief Summary
The existence of supracrestal tissue attachment (SCTA) is fundamental for adhesion of the junctional epithelium and insertion of the connective fibers to the dental structure, besides functioning as a barrier against microbial entry in the periodontium. Wide variation in SCTA dimension have been reported in patients with and without periodontitis. If the physiologic dimension of SCTA is violated then it may lead to inflammation in periodontium. Influence of dimension of SCTA on scaling and root planning and open flap debridement procedure has not been investigated till date. Thus the aim of study is to assess the influence of SCTA dimension on the outcome of scaling and root planning followed by open flap debridement in patients with stage 2 and stage 3 periodontitis and also to estimate the SCTA dimension in thick versus thin periodontal phenotype.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedJune 27, 2023
June 1, 2023
1.1 years
January 13, 2023
June 24, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
CLINICAL ATTACHMENT LEVEL (CAL)
Clinical Attachment Level will be measured as the distance between the base of the clinical pocket and the cemento-enamel junction(CEJ).Measurements will be made at 6 sites of involved tooth- mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto- lingual using UNC-15 probe.
6 MONTHS
BLEEDING ON PROBING (BOP)
BOP will be recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as % sites with bleeding on probing.
6 MONTHS
PROBING POCKET DEPTH (PPD)
Probing pocket depth will be measured as the distance from the gingival margin to the base of the clinical pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP-UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio- lingual, mid-lingual, disto-lingual. Measurements will be rounded to the nearest whole millimetre.
6 MONTHS
Study Arms (2)
Thick periodontal phenotype
EXPERIMENTALScaling and root planing and open flap debridement in patients with stage II and stage III periodontitis
Thin periodontal phenotype
ACTIVE COMPARATORScaling and root planing and open flap debridement in patients with stage II and stage III periodontitis
Interventions
Scaling and root planing involves removal of plaque and calculus. Open Flap debridement involves reflection of full thickness mucoperiosteal flap, thorough debridement of the surgical site and approximation and suturing of the flap at the original position.
Eligibility Criteria
You may qualify if:
- Patients with generalised stage II or stage III periodontitis
- Maxillary or mandibular incisors having same periodontal phenotype
You may not qualify if:
- Patient with systemic diseases like uncontrolled diabetes, hypertension, bleeding disorders, coronary artery disease etc.
- Malaligned teeth
- Patient having undergone any periodontal therapy within one year
- Pregnant and lactating females
- Patient on antibiotic therapy in the past one month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SAKSHI VERMA, BDS
POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2023
First Posted
January 25, 2023
Study Start
February 1, 2023
Primary Completion
February 28, 2024
Study Completion
March 31, 2024
Last Updated
June 27, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share