Clinical and Radiographic Evaluation of Three Different Modalities for Management of Distal Extension Atrophied Mandibular Ridge: A One Year Prospective Study

NCT05978115 | Unknown

• 1 other identifier: A01020822
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Nine patients selected for this study with mandibular free end saddle and atrophied posterior ridge according to treatment options all patients will be divided randomly into 3 groups:

• Group A: included three participants who will receive implant retained partial overdentures
• Group B: included three participants who will receive short implants supported fixed prosthesis
• Group C: included three participants who will receive long implant supported fixed prosthesis after ridge augmentation.
• For Group A: Implant retained partial overdenture The implants will be inserted in first premolar areas and partial overdenture will be connected with implant by locator attachment.
• For Group B: Short implant supported fixed prosthesis The implants will be inserted in first premolar, second premolar, and first molar areas without any ridge augmentation and the implant will be connected by fixed prosthesis
• For group C: Long implant supported fixed prosthesis after ridge augmentation The implants will be inserted in first premolar, second premolar, and first molar areas with ridge augmentation by using Khoury technique17 and the implants will be connected by fixed prosthesis
• Clinical evaluation will be made in terms of:
• Gingival Index (GI)
• Plaque Index (PI)
• Pocket Depth (PD)
• Width of Keratinized Mucosa (KM)
• Implant Stability (ISQ).
• Radiographic evaluation will include mandibular residual ridge resorption using the proportional area measurements. evaluation periods will be performed at time of insertion T(0), 6 months after insertion T(6), 12 months after insertion T(6)

Conditions

Different Treatment Outcomes of Atrophied Distal Extension Cases

Outcome Measures

Primary Outcomes (5)

• Gingival Index (GI)

  Modified gingival index will be recorded according to Mombelli et al, as follows: score 0; normal gingival, score 1; mild inflammation (slight change in color \& slight edema), but no bleeding on probing, score 2; moderate inflammation (redness \& edema), and bleeding on probing, and score 3; sever inflammation (marked redness, edema \& ulceration) with tendency to spontaneous bleeding.

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

• Plaque Index (PI)

  Plaque will be assessed according to modified plaque index describe by Mombelli et al. as follows: score 0; no plaque detected, score 1; plaque recognized only by running a probe across a smooth marginal surface of the implant, score 2; plaque can be seen by naked eye, and score 3; abundance of soft mater.

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

• Pocket Depth (PD)

  Using a calibrated plastic periodontal probe, the distance between marginal border of the gingiva and the tip of the probe will be measured in mm and considered as pocket depth (PD).

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

• Width of Keratinized Mucosa (KM)

  The width of peri-implant keratinized mucosa will be measured in mm using a calibrated plastic periodontal probe. Differences in color, texture and mobility between the keratinized mucosa and the lining mucosa served as markers for the detection of the muco-gingival junction. KM was then measured as the distance between the gingival margin and the muco-gingival junction.

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

• Implant Stability (ISQ)

  Implant stability will be assessed using resonance frequency analysis (RFA). The resonance frequencies will be measured with the osstell® device (implant stability meter) and expressed with ISQ measurement scale (implant stability quotient).

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Study Arms (3)

short implant supported removable partial overdenture

EXPERIMENTAL

Procedure: implant supported prosthesis

short Implant supported fixed partial denture

EXPERIMENTAL

Procedure: implant supported prosthesis

Ridge Augmentation and implant supported fixed partial denture

EXPERIMENTAL

Procedure: implant supported prosthesis

Interventions

implant supported prosthesis PROCEDURE

Group A: short dental implant placement + Removable partial denture Group B: Short implant placement + Fixed partial denture Group c: Bone Augmentation + Implant placement + Fixed Partial denture

Also known as: Bone augmentation for atrophied ridge

Ridge Augmentation and implant supported fixed partial denture; short Implant supported fixed partial denture; short implant supported removable partial overdenture

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrophied partially edentulism in the posterior mandible having a residual bone height of 6-8mm bone between inferior alveolar nerve and crest of the ridge to receive implants
• Residual alveolar ridges covered with healthy mucosa without any signs of inflammation or remaining roots.
• Normal maxilla-mandibular relationship with sufficient available restorative space.

You may not qualify if:

• Patients with the following conditions will be excluded:
• Diseases that affect bone metabolism, eg: uncontrolled diabetes, hyperparathyroidism, and osteoporosis.
• Systemic diseases that may affect osteointegration or complicate surgical procedures, eg: liver diseases, heart diseases and radiotherapy in head and neck region.
• Abnormal or harmful habits eg: smoking, bruxism, and clenching.
• Uncooperative patients and patients with poor oral hygiene.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

Location

Related Publications (1)

• Raffat EM, Shady M, Elkashty AAR, Syad ME. Comparative analysis of implant survival, peri-implant health, and patient satisfaction among three treatment modalities in atrophic posterior mandibles: a randomized clinical study. BMC Oral Health. 2025 Jun 7;25(1):939. doi: 10.1186/s12903-025-06286-7.

  PMID: 40483406 DERIVED

MeSH Terms

Interventions

Dental Prosthesis, Implant-Supported

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Mohamed Shady, MD

  Mansoura University Faculty of Dentistry, Prosthodontics department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: August 20, 2021
• Primary Completion: November 20, 2022
• Study Completion: February 1, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-07

Locations

EG (1)