Randomized Clinical and Radiographic Study

NCT06609720 | Completed

• 1 other identifier: OMPDR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical and radiographic trial

Conditions

Autogenous Dentin Graft

Keywords

dentin graft, tooth graft

Outcome Measures

Primary Outcomes (3)

• Probing pocket depth

  According to Ramfjord, clinical parameter measured by UNC periodontal probe from a fixed point to the deepest probing depth. Using stent to standardize the measurements.

  Measured at baseline, 6 months and 12 months

• Clinical attachment level

  According to Ramfjord, clinical parameter measured by a Naber\'s probe. Using stent to standard measurements.

  Measured at baseline, 6 months and 12 months

• Bleeding on probing

  According to Ramfjord, the bleeding at each site observed after probing and recorded positive if bleeding was observed within 30 seconds, if not was recorded as negative.

  Measured at baseline, 6 months and 12 months

Secondary Outcomes (1)

• Radiographic outcome

  measured at baseline and 1 year follow up

Study Arms (4)

Group 1 subgroup A

EXPERIMENTAL

Grade II furcation involvement treated with autogenous dentin graft

Procedure: (guided tissue regeneration)

Group 1 Subgroup B

EXPERIMENTAL

Grade II furcation involvement treated with demineralized freeze-dried bone allograft

Procedure: (guided tissue regeneration)

Group II subgroup A

EXPERIMENTAL

Grade III furcation involvement treated with Autogenous dentin graft

Procedure: (guided tissue regeneration)

Group II subgroup B

EXPERIMENTAL

Grade III furcation involvement treated with demineralized freeze-dried bone allograft

Procedure: (guided tissue regeneration)

Interventions

(guided tissue regeneration) PROCEDURE

Randomized clinical and radiographic trial

Group 1 Subgroup B; Group 1 subgroup A; Group II subgroup A; Group II subgroup B

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.
• Horizontal probing depth ≥3 mm using Naber's probe.
• Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.
• Evidence of radiolucency in the furcation area on panoramic radiograph.
• Patients who will be assigned for groups (I and II) should present with teeth required for extraction due to advanced periodontal bone loss or other indications such as hopeless wisdom teeth or orthodontic indications or unrestorable fractured teeth as a source for autogenous dentin graft (ADG).

You may not qualify if:

• Medically compromised patients and systemic conditions precluding periodontal surgery.
• Mandibular first or second molars with root caries or endodontic treatment.
• Smokers, diabetics, pregnant or lactating women.
• History of chemotherapy, radiotherapy in head and/or neck region.
• Bisphosphonate therapy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of dentistry

Tanta, Egypt

Location

MeSH Terms

Interventions

Guided Tissue Regeneration

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Banan L Amer, Master

  Tanta University

  PRINCIPAL INVESTIGATOR

• Samia A Darwish, Professor

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at periodontology department, Principal Investigator, MSC

Model Details: 2 groups with 2 subgroups, each subgroup receive either ADG or DFDBA

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: September 24, 2024
• Study Start: March 1, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 30, 2023
• Last Updated: September 24, 2024

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)