Evaluation of Peri-Implant Tissues of Different Implant Assisted Overdentures

NCT06647199 | Completed

• 1 other identifier: Mansoura
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers will perform a parallel randomized, clinical trial involving completely edentulous healthy patients. Each participant will receive four dental implants in the anterior mandible. According to the processing technique and denture base material, the patients will be classified into three groups. Group I: involves CAD/CAM milled poly ether ether ketone PEEK overdentures, Group II: involves CAD/CAM milled PMMA overdentures and Group III :involves conventional heat-cured poly methyl methacrylate PMMA overdentures. All assessments were carried out at delivery, 6 moths and one year after overdenture insertion to clinically evaluate the preiimplant tissues. .

Conditions

Peri-Implant Tissues

Outcome Measures

Primary Outcomes (3)

• Peri-Implant Tissues changes regarding plaque index (PI).

  Peri-implant soft tissue changes as regards plaque was assessed employing the modified plaque index (PI).

  2 years

• Peri-Implant Tissues changes regarding The bleeding index (BI).

  The bleeding index in accordance with Mombelli et al was used: score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding.

  2 years

• Peri-Implant Tissues changes regarding The gingival index (GI)

  The modified Silness and Loe index, was used to calculate the gingival index: Score 0: normal peri implant mucosa; score 1: mild inflammation, slight color change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.

  2 years

Study Arms (3)

CAD/CAM Milled PEEK

EXPERIMENTAL

In the first group (CAD/CAM PEEK MODs), the mandibular master cast, mandibular trial denture, and maxillary denture were scanned using an intraoral digital scanner both separately while biting. The scanned data were saved in standard tessellation language (STL) file format and entered into the design software . The mandibular denture base and set-up were virtually designed. Based on the virtually created mandibular denture bases, the STL file of the designed denture base was imported into the milling machine to mill the prepolymerised PEEK discs to construct the CAD/CAM PEEK MOD base .

Procedure: the plaque index (PI); Procedure: the bleeding index (BI); Procedure: simplified gingival index(GI),

CAD/CAM milled PMMA

EXPERIMENTAL

In the second group (CAD/CAM PMMA MODs), the STL file of the designed denture base was imported into the milling machine to mill the PMMA MOD base. The mandibular denture base and set-up were virtually designed. Based on the virtually created mandibular denture bases, the CAD/CAM PMMA MOD base was milled .Based on the scanned denture teeth, denture teeth were milled from tooth-coloured prepolymerized PMMA blocks, finished and polished, and then bonded with a methacrylate-based bonding agent into the PMMA milled base.

Procedure: the plaque index (PI); Procedure: the bleeding index (BI); Procedure: simplified gingival index(GI),

conventional PMMA MOD

EXPERIMENTAL

the traditional heat-cured PMMA MOD was constructed. The waxed-up overdenture was processed in heat-cured PMMA resin using the compression mould technique.

Procedure: the plaque index (PI); Procedure: the bleeding index (BI); Procedure: simplified gingival index(GI),

Interventions

the plaque index (PI) PROCEDURE

Peri-implant soft tissue changes as regards plaque was assessed employing the modified plaque index (PI). Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD).

CAD/CAM Milled PEEK; CAD/CAM milled PMMA; conventional PMMA MOD

the bleeding index (BI) PROCEDURE

Peri-implant tissue changes as bleeding score was assessed employing the bleeding index (BI) . Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD).

CAD/CAM Milled PEEK; CAD/CAM milled PMMA; conventional PMMA MOD

simplified gingival index(GI), PROCEDURE

Peri-implant soft tissue changes as regards gingival scores was assessed simplified gingival index(GI). Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD

CAD/CAM Milled PEEK; CAD/CAM milled PMMA; conventional PMMA MOD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Each selected subject fulfilled the following criteria:
• all subjects complained about insufficient retention and stability pertained to their mandibular dentures at their presentation;
• they had enough quantity and quality of bone in the mandibular lateral and canine areas to support the standard implants (14 mm in length and 3.6 mm in diameter) as verified by CBCT;
• they had healthy keratinized mucosa and a class I maxillomandibular relationship; besides, they had enough interarch space.

You may not qualify if:

• Diabetes, osteoporosis, and immunological deficiency
• subjects having head and neck radiation therapy or using anticoagulant medication.
• Those who had a history of temporomandibular joint dysfunction, which could interfere with appropriate function,
• those who smoked heavily were also excluded.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35561, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of prosthodontics

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: December 1, 2020
• Primary Completion: January 20, 2022
• Study Completion: July 22, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

EG (1)