Clinical trial NCT04769271: Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis
Official title: Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis (A Clinical and Biochemical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess clinically and biochemically the effect of intrapocket application of tea tree oil (TTO) gel adjunctive to SRP in the management of stage 2(moderate) periodontitis and to correlate the biochemical levels with clinical response.

Detailed description: A randomized, controlled clinical trial included thirty patients with stage 2 periodontitis. They were equally divided into two groups: Group 1 (control group) treated with scaling and root planning (SRP) alone and Group 2 (test group) managed by SRP and locally delivered 5% tea tree oil (TTO) gel.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with stage 2,grade B periodontitis according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
* Patients with CAL 3-4 mm , BOP and radiographic horizontal bone loss related to the coronal third of the root (15%-33%).
* Patients with no teeth loss due to periodontitis.
* Patients with radiographic bone loss/age % of 0.25-1 %.
* Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study.

Exclusion Criteria:

* Patients with CAL caused by non periodontal causes.
* Patients with grade C periodontitis.
* Patients having any systemic disease that may affect the treatment outcomes
* Smokers.
* Pregnant females.
* Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.

Primary outcomes:
measure: Probing depth
timeFrame: up to 6 months
measure: Clinical attachment loss
timeFrame: up to 6 months
measure: Bleeding on probing
timeFrame: up to 6 months
measure: Biochemical assessment of inlammation
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha R. Taalab, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Dania M. Abdel Aziz, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Biochemistry and Molecular Biology department. Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
name: Sabah A Mahmoud, PhD
role: STUDY_DIRECTOR
affiliation: Pharmaceutics department. Faculty of Pharmacy, Alexandria University; Alexandria, Egypt.
name: Riham M El Moslemany, PhD
role: STUDY_DIRECTOR
References:
citation: Taalab MR, Mahmoud SA, Moslemany RME, Abdelaziz DM. Intrapocket application of tea tree oil gel in the treatment of stage 2 periodontitis. BMC Oral Health. 2021 May 5;21(1):239. doi: 10.1186/s12903-021-01588-y.