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NCT Number: NCT06643663

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

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.

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Key information

Conditions

Periapical Diseases Dental Pulp Diseases Endodontic Disease Jaw Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endodontic Micro-Surgery

Procedure

Surgery performed using ACM membrane and PRF plug in test group & without membrane & PRF in control group.

Primary outcomes

  1. Periapical healing assessment

    Time frame: Base line to 12 months

    Periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D Criteria. Healing will be categorised into complete, incomplete, uncertain, unsaisfactory.

Secondary outcomes

  1. Quality of life assessment

    Time frame: Base line to 12 months

    to assess pain, swelling, mouth opening and effect on daily activities of patient among test and control group using OHIP-14 questionnaire. Pain Assesment with Value 0 indicate no pain & 100 indicate maximum pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Parichay Singhal, MDS

CONTACT

[email protected]

9717710642

Dr. Shweta Mittal, MDS

CONTACT

[email protected]

9255596960

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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