PGIDS
Rohtak, Haryana, 124001, India
Location status: Recruiting
Location contact
DR. Sanjay Tewari, MDS
CONTACT
Mareesha, PG student
CONTACT
NCT Number: NCT07048171
To determine the effect of allograft and iPRF with or without collagen membrane on healing of apicomarginal defects : A Randomized Controlled Trial
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rohtak, Haryana, 124001, India
Location status: Recruiting
DR. Sanjay Tewari, MDS
CONTACT
Mareesha, PG student
CONTACT
RATIONALE: - Apicomarginal defects are characterized by localized alveolar bone loss spanning the entire length of the root from the crestal alveolar bone to the apex of the tooth. These defects often present as a challenge in endodontic and periodontal therapy due to their extensive involvement of both the root apex and the periodontal tissues. .The use of guided tissue regeneration techniques has been proposed as an adjunct to endodontic surgery in order to promote bone healing Guided tissue regeneration (GTR) is a technique which prevent epithelial down growth, if the epithelial cells are excluded from a wound long enough for other cells types with regenerative potential to become established. Till date about 14 studies have been done on apicomarginal defects involving 12 on human and 2 on animal studies. Many studies have used either membrane alone , membrane and bone graft , only membrane or periosteal bone graft/ autologus platelet concentrate for promoting healing in such defects. .Both membrane ,graft as well as combination of membrane and graft may act a space maintainer to prevent epithelial migration .No study so far has compared three dimensional healing after endodontic surgery with adjunct use of graft with or without use of membrane in apicomarginal defects. Nevertheless there has been no study with the use of allograft and iPRF with collagen membrane versus allograft and iPRF in the healing of apicomarginal defects and quality of life assessment.
AIM To assess whether the application of allograft and iPRF with collagen membrane leads to improved healing outcomes and enhanced quality of life compared to the use of only allogafts and iPRF in patients of apicomarginal defects .
PRIMARY OBJECTIVE To evaluate the impact of application of allograft and iPRF with collagen membrane on buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). & modified PENN 3D criteria.
SECONDARY OBJECTIVE To compare quality of life of patients after periapical surgery with use of allograft and iPRF with collagen membrane and allograft and iPRF without collagen membrane in cases of apicomarginal defects .
SETTING: -Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.
STUDY DESIGN: - A randomized controlled trial
TIME FRAME: - 12Months
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
6.Failed primary root canal treatment 7.Adequate final restoration with no clinical evidence of coronal leakage.
Exclusion criteria
Surgery performed using bone graft(DFDBA) and iPRF with collagen membrane in test group and bone graft and iPRF without collagen membrane in control group
Time frame: Base line to 12 months
Periapical healing comparison in 2 groups with buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). & modified PENN 3D criteria .
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.
Contact information is provided by the study sponsor or research team.
DR. Sanjay Tewari, MDS
CONTACT
Mareesha Mareesha, PG student
CONTACT
Postgraduate Institute of Dental Sciences Rohtak
Other
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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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