Effect of Combined Use of an Allograft and Membrane on the Healing Outcome of Apicomarginal Defects

Apicomarginal Defects Clinical Trial

Official title:

Effect of Combined Use of an Allograft and a Membrane on the Healing Outcome of Apicomarginal Defects Using 2D and 3D Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171543
• Other study ID #: Rahul Sharma
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2021
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Healing of apicomarginal defects using 2 different groups, one being treated with the use of an allograft and a membrane and a control group, will be assessed and compared using 2D and 3D criteria. Also,quality of life will be compared between the two groups.

Description:

Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region.

Various resorbable and non resorbable collagen membrane with or without xenograft, allograft and alloplastic materials have been used in different studies. Although animal studies have reported high success rates with the use of bone graft materials and membranes over the controls but no human study till date has evaluated or compared the effect of using an allograft and membrane versus Control.

Thus, the aim of the present study is to investigate to two hypothesis. The first null hypothesis stated that there would be no difference between quality of life and healing outcome of periapical defects with periodontal communications following surgery using membrane with allograft and the conventional control group utilizing no GTR technique. The second null hypothesis stated that there would be no difference in outcome derived from the assessment of 2D periapical radiographs and 3D CBCT imaging.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• 1. Age 16 years and older consenting to the surgical procedure as well as agreeing to preoperative and at least 1 follow-up CBCT evaluation after 12 months 2. Noncontributory medical history (American Society of Anesthesiologists class I and II)

3. Patients with a deep narrow pocket with probing depth >6 mm confined to buccal aspect of the root, 4. Negative response to vitality tests, 5. Radiographic evidence of radiolucency, 6. Failed previous root canal treatment and retreatment at least 1 year previously, 7. Previous surgery with unresolved bony lesion, 8. Recurrent episodes of purulent discharge, and 9. Adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria:

• 1. Patients with medical history with American Society of Anesthesiologists class III to V or Any systemic disease contraindicating oral surgical procedures, potentially affecting the healing process.

2. Chronic generalized periodontitis, 3. Evidence of root fracture, 4. resorptive processes involving more than apical third of the root

Related Conditions & MeSH terms

• Apicomarginal Defects

Intervention

Procedure:
• Periapical surgery with placement of an allograft and a membrane
Periapical surgery will be done followed by placement of an allograft into the defect and a membrane over the defect before closure of the flap.

Locations

Country	Name	City	State
India	Sanjay Tewari	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of apicomarginal defects.	Patients will be checked clinically for absence of signs and symptoms. Radiographic 2D assessment will be done by Rud and Molven criteria as follows:-; Complete healing- defined by re-establishment of the lamina dura Incomplete healing (scar tissue) Uncertain healing Unsatisfactory healing (failure). 3D healing will be assessed by modified PENN 3D criteria(Schloss et al) as-; Complete healing Limited healing Uncertain healing Unsatisfactory healing.	Baseline to 12 months
Secondary	Assessment of quality of life	All patients will be given a questionnaire (Igor Tsesis et al) with 15 questions to evaluate their quality of life for 7 days postsurgery.	Baseline to day 7 postoperatively