Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication

Postgraduate Institute of Dental Sciences Rohtak

Status: Enrolling

Conditions: Endodontic Disease; Periapical Diseases

Treatments: Procedure: Endodontic Micro-Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06643663

Parichay Singhal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Pt with apicomarginal defects & interproximal bone loss receiving GTR

Experimental group

Description:

Surgery performed using ACM membrane and PRF plug.

Treatment:

Procedure: Endodontic Micro-Surgery

Pt with apicomarginal defects & interproximal bone loss without GTR

Active Comparator group

Description:

Surgery performed without ACM membrane and PRF plug.

Treatment:

Procedure: Endodontic Micro-Surgery