Clinical trial NCT06643663: Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
Official title: "Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periapical Diseases
Endodontic Disease
Keywords: Guided tissue regeneration
healing
endo-perio lesions
endodontic surgery
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. More recently, autologous platelet concentrate plug \& placental membrane have emerged as a treatment option for addressing such lesions. Nevertheless, there has been no study using PRF-Medium with ACM membrane on the healing of aforesaid lesion \& quality of life assessment.

Detailed description: RESEARCH QUESTION (PICO) Does the combined application of PRF-Medium plug and ACM membrane lead to superior healing outcomes compared to conventional technique in treating apico-marginal defects with interproximal involvement? AIM \&OBJECTIVES: - AIM To assess whether the combined application of PRF-Medium and ACM membrane leads to improved healing outcomes and enhanced quality of life compared to conventional techniques in patients of apico-marinal defects with interproximal involvement. PRIMARY OBJECTIVE

1. To evaluate the impact of combined application of PRF-Medium and ACM membrane on healing outcomes in cases of apico-marginal defects with interproximal involvement with 2D periapical radiographs \& 3D CBCT imaging. SECONDARY OBJECTIVE
2. To evaluate and compare differences in quality of life of patients after periapical surgery with use of PRF-Medium and ACM membrane in cases of apico-marginal defects with interproximal involvement. PICO P(Population)- Patients with non-vital teeth and persistant chronic suppurative apical periodontitis with apico-marginal defects and interproximal involvement. I(Intervention)-Endodontic surgery followed by placement of PRF-Medium plug and ACM membrane. C(Comparison)-Endodontic surgery without using any plug and membrane. O(Outcome)- Periapical healing after surgery in both groups.

Eligibility criteria: Inclusion Criteria:

1. Patients of age 16yrs and above.
2. Patients with apico-marginal defects and deep pocket upto apex of tooth.
3. Failed primary root canal treatment.
4. Presence of interproximal bone loss.
5. Negative response to vitality test.
6. ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)

Exclusion criteria:

1. Presence of vertical root fracture
2. Presence of root perforations
3. ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists)
4. Presence of root resorption
5. Combined endodontic-periodontic lesions.
6. Pregnancy

Primary outcomes:
measure: Periapical healing assessment
timeFrame: Base line to 12 months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: Base line to 12 months
Other outcomes:
Locations:
city: Haryana
country: India
facility: Pgids Rohtak
Study officials:
affiliation: PGIDS, Rohtak, Haryana, 124001
name: Dr, Sanjay Tewari, MDS
role: STUDY_DIRECTOR
References: