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Recruiting NCT06643663

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

No phase Interventional Periapical Diseases Endodontic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endodontic Micro-Surgery.
Who it may be relevant to
Registry conditions: Periapical Diseases, Endodontic Disease. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

"Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"

Overview

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.

Interventions

  • Procedure Endodontic Micro-Surgery
    Surgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group.

Primary outcome measures

  • Periapical healing assessment [Time frame: Base line to 12 months]
Secondary outcome measures (1)
  • Quality of life assessment [Time frame: Base line to 12 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

India · 1 center
  • Pgids Rohtak — Haryāna

Identifiers

NCT: NCT06643663 · Parichay Singhal

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗