- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07678125
Influence of Re-evaluation Timing After Phase I Periodontal Therapy on Clinical and Periodontal Outcomes.
Influence of Re-evaluation Timing After Phase I Periodontal Therapy on Clinical and Periodontal Outcomes. A Split-mouth Study
Periodontal disease remains a highly prevalent chronic inflammatory condition affecting the supporting structures of the teeth and is a leading cause of tooth loss worldwide. Contemporary periodontal therapy is structured into sequential phases, with non-surgical periodontal therapy (NSPT) forming the cornerstone of initial management. Following this phase, re-evaluation of periodontal status is critical to determine treatment outcomes and guide further intervention, including surgical therapy if required (1,2).
Re-evaluation phase serves multiple purposes: it allows assessment of tissue response to therapy, measurement of reductions in probing pocket depth (PPD), gains in clinical attachment level (CAL), and evaluation of patient compliance with oral hygiene practices. It also aids in identifying residual pockets or persistent inflammation that may necessitate additional treatment (1,3). Despite its clinical importance, the optimal timing of re-evaluation remains inconsistently defined in the literature (1). Generally, current literature utilizes a timing frame from 1-3 months; up to 9 months (3,4). Current clinical guidelines, including those from the European Federation of Periodontology (EFP), generally recommend assessing whether the end points have been achieved; no periodontal pockets ≥ 5mm with bleeding on probing and no pocket ≥ 6mm (5).
Emerging evidence suggests that certain clinical improvements, particularly reductions in inflammation and bleeding on probing (BOP), may occur as early as 4 weeks following therapy, raising questions about whether earlier re-evaluation could be clinically beneficial (2,3). Early reassessment may allow for more timely identification of non-responding sites, enabling prompt intervention and potentially improving overall treatment outcomes. Conversely, other studies indicate that full periodontal healing and maturation of tissues may require longer periods, supporting delayed re-evaluation intervals (1,2,3).
Furthermore, patient-related factors such as systemic health, smoking status, and baseline disease severity may influence healing dynamics and thus the appropriate timing for reassessment (1). The heterogeneity of these factors highlights the potential need for a more individualized approach to re-evaluation rather than a fixed universal timeframe.
Despite these considerations, there is a notable lack of high-quality comparative studies directly evaluating short-term versus conventional re-evaluation intervals following NSPT. Most available studies focus on treatment outcomes rather than the timing of reassessment itself. This creates a significant gap in the literature, particularly regarding whether earlier re-evaluation could enhance clinical decision-making, improve patient outcomes, or optimize resource utilization in clinical practice.
In addition, with increasing emphasis on minimally invasive and patient-centered care, there is a growing need to refine periodontal treatment protocols to ensure efficiency without compromising effectiveness. Determining the optimal timing of re-evaluation could contribute to improved treatment planning, reduced disease progression, and enhanced long-term periodontal stability.
Therefore, this study aims to address this gap by investigating the effectiveness and clinical implications of shorter re-evaluation intervals following periodontal therapy, compared to conventional timeframes.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nesma Shemais, PhD
- Phone Number: 0529961988
- Email: dr.nesma@gmu.ac.ae
Study Locations
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, United Arab Emirates, 00000
- Gulf Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients above 18 yrs
- Patients that are systemically healthy
- Patients diagnosed as Stage III or Stage IV Periodontitis
- Patients willing to participate in the study and provide informed consent.
- Patients with no recent history of periodontal therapy
- Presence of ≥20 natural teeth
Exclusion criteria:
- Patients with a history of medical conditions or diseases that may affect healing or periodontal tissues.
- Patients who are pregnant
- Patients on Drugs/medication that may affect the periodontal tissue
- Smokers or tobacco users
- Patients that cannot complete the 12-week follow-up period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Re-evaluation Group 4 weeks
Test group with periodontal re-evaluation at 4 weeks following non-surgical periodontal therapy.
|
Test group with periodontal re-evaluation at 4 weeks following non-surgical periodontal therapy
|
|
Active Comparator: Delayed Re-evaluation Group 10 - 12 weeks
Control group with periodontal re-evaluation at 8-10 weeks following non-surgical periodontal therapy
|
Control group with periodontal re-evaluation at 8-10 weeks following non-surgical periodontal therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
clinical attachment level
Time Frame: baseline, 4 weeks, 10 weeks
|
baseline, 4 weeks, 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
probing depth
Time Frame: baseline, 4 weeks, 10 weeks
|
baseline, 4 weeks, 10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RabeeaMDSperio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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