Comparison of Non Perforated Titanium Foil Over Collagen Membrane in Ridge Augmentation.

NCT07162727 | Completed

• 1 other identifier: SVSIDS/PERIO/3/2022
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Aim \& Objectives: The aim of the present study was to clinically and radiographically evaluate the efficacy of titanium foil and collagen membrane in ridge augmentation. Patients and methods: 18 subjects participated in this study. One site in each subjects was randomly assigned into each of the following experimental groups; Test group: ridge augmentation with titanium foil and control group: ridge augmentation with collagen membrane. Radiographic parameters included bone height, bone width and bone density. Evaluations of these parameters were performed after 3 months and 6 months by using Dentium Rainbow software \& \[reg\]. Clinical parameters included the evaluation of Early Healing Score (EHS) during post operative healing period at 1 week and 1 month.

Conditions

Ridge Augmentation

Keywords

Alveolar ridge augmentation; Bone height; Bone width; Bone density

Outcome Measures

Primary Outcomes (3)

• bone height

  BH was measured from the crest of the alveolar ridge to the superior border of the mandibular canal in the mandible or to the floor of the nasal cavity or maxillary sinus in the maxilla. These measurements were recorded in millimeters (mm) at the center of the edentulous region.

  6 months

• bone width

  Bone width was measured in the buccolingual dimension at three standardized levels: 1 mm below the crest (crestal level), mid-height of the alveolar ridge, basal bone (near cortical base). These measurements were done perpendicular to the long axis of the alveolar ridge using the ruler tool in the software.

  6 months

• bone density

  Bone density was assessed using CBCT grayscale values (GV) as a surrogate for bone mineral density. Although it is not equivalent to Hounsfield Units (HU), relative GV were used for intra-study comparison. A 1 mm² region of interest (ROI) was selected at each measurement level (crestal, middle, and basal). GV values were recorded and averaged for statistical analysis.

  6 months

Secondary Outcomes (1)

• early healing score

  1 month

Study Arms (2)

titanium foil in ridge augmentation

EXPERIMENTAL

Full thickness mucoperiosteal flap was elevated, to expose the alveolar ridge defect. HA graft was placed onto the external defect upon which preformed titanium foil (Ti-foil®, India) depending on the size and extent of defect was placed. Foil was stabilized with the help of stainless steel screws of diameter 1.5 cm and length varied depending on the depth of the defect. The flaps were approximated and sutured without tension. Periodontal dressing was given.

Device: titanium foil in ridge augmentation

collagen membrane in ridge augmentation

ACTIVE COMPARATOR

Full thickness mucoperiosteal flap was elevated, to expose the alveolar ridge defect. HA graft was placed onto the external defect upon which preformed collagen membrane depending on the size and extent of defect was placed. The flaps were approximated and sutured without tension. Periodontal dressing was given.

Device: collagen membrane

Interventions

titanium foil in ridge augmentation DEVICE

Full thickness mucoperiosteal flap was elevated, to expose the alveolar ridge defect. HA graft was placed onto the external defect upon which preformed titanium foil depending on the size and extent of defect was placed. Foil was stabilized with the help of stainless steel screws of diameter 1.5 cm and length varied depending on the depth of the defect. The flaps were approximated and sutured without tension. Periodontal dressing was given.

titanium foil in ridge augmentation

collagen membrane DEVICE

Full thickness mucoperiosteal flap was elevated, to expose the alveolar ridge defect. HA graft was placed onto the external defect upon which preformed collagen membrane depending on the size and extent of defect was placed. The flaps were approximated and sutured without tension. Periodontal dressing was given.

collagen membrane in ridge augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy male and female patients of age \>18 years with atropic areas.
• Class IV (knife edge form with adequate height but in adequate width of alveolar process) and V (flat ridge form with loss of alveolar process) of Cawood and Howell27 classification.

You may not qualify if:

• Medically compromised patients
• patients \<18 years of age
• pregnant women
• bruxism patients
• heavy smokers
• patients who underwent chemotherapy, radiotherapy in the past 12 months.

Sponsors & Collaborators

• Dr R Viswa Chandra: lead
• SVS Institute of Dental Sciences: collaborator

Study Sites (1)

Svs Institute of Dental Sciences

Mahbūbnagar, Telangana, 509001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and head of the department

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 9, 2025
• Study Start: April 13, 2023
• Primary Completion: September 25, 2024
• Study Completion: March 14, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IN 2026

Locations

IN (1)