Treatment of Peri-implant Bone Dehiscence Using Autogenous Tooth Plate

NCT06313216 | Completed DMC

• 1 other identifier: KFSIRB200-187
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft. The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate.

Conditions

Implant Complication; Peri-Implantitis; Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• Stability Quotient of dental implant (SQDI)

  Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means \>70 ISQ, between 60-69 is medium stability and \< 60 ISQ is considered as low stability.

  12-month.

• pink esthetic score (PES)

  The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14

  12-month.

• facial marginal bone level (FMBL)

  Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.

  12-month.

Study Arms (3)

Immediate Implant Placement Using duoteck membrane

EXPERIMENTAL

after insertion of immediate implant, the dehisced bone defect will be grafted Using duoteck membrane

Procedure: duoteck membrane

Immediate Implant Placement autogenous demineralized tooth graft

EXPERIMENTAL

after insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft

Procedure: autogenous demineralized tooth graft

Immediate Implant Placement with autogenous demineralized tooth graft and tooth plate

EXPERIMENTAL

after insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft and autogenous demineralized tooth plate

Procedure: autogenous demineralized tooth graft and plate

Interventions

duoteck membrane PROCEDURE

the dehisced bone defect will be covered with duoteck membrane

Immediate Implant Placement Using duoteck membrane

autogenous demineralized tooth graft PROCEDURE

the dehisced bone defect will be covered with autogenous demineralized tooth graft

Immediate Implant Placement autogenous demineralized tooth graft

autogenous demineralized tooth graft and plate PROCEDURE

the dehisced bone defect will be covered with autogenous demineralized tooth graft combined with autogenous demineralized tooth plate

Immediate Implant Placement with autogenous demineralized tooth graft and tooth plate

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• above the age of 18years
• presence of non-restorable maxillary anterior tooth
• had intact socket walls following tooth extraction
• the gingival biotype was thick.

You may not qualify if:

• history of systemic condition
• history of using bisphosphonates or other drugs that might impact bone turnover
• a history of smoking during the previous five years,
• a history of any acute infections at the surgical site,
• teeth having root resorptions

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases

Interventions

Bone Plates

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Walid AH Elamrousy, PhD

  Faculty of Oral and Dental Medicine, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: neither participant nor the outcome assessor know the group distribution
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Model Details: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with duoteck membrane, while group II was grafted by autogenous demineralized tooth graft, but group III was grafted with autogenous demineralized tooth graft with autogenous demineralized tooth plate Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: March 15, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

EG (1)