NCT04353999

Brief Summary

The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 11, 2020

Last Update Submit

April 16, 2020

Conditions

Soft Tissue Healing

Outcome Measures

Primary Outcomes (1)

  • Soft tissue healing (the changes in the soft tissue color throughout the first month)

    clinical examination and scoring according to Landry healing index. A score of 1 to 5 was given to the surgical site indicating the improvement of the nature of the soft tissue . A score of 1 meaning the least healing and 5 being excellent healing.

    at 2nd, 3rd and 4th week

Secondary Outcomes (3)

  • soft tissue thickness in millimeters.

    4 months

  • Bone width and height measured in millimeters

    4 months

  • pain score on the visual analogue scale (VAS)

    1 week

Study Arms (2)

980 nm diode laser photocoagulation

EXPERIMENTAL

980 nm diode laser was used to coagulate the blood over the bone graft particles and achieve a socket seal after socket grafting

Procedure: Socket sealing by diode laser photocoagulation

Dense polytetrafluroethylene membrane

ACTIVE COMPARATOR

dPTFE membrane was used to seal the socket after grafting

Procedure: socket sealing with dense polytetrafluroethylene membrane

Interventions

Socket sealing by diode laser photocoagulationPROCEDURE

tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes

980 nm diode laser photocoagulation
socket sealing with dense polytetrafluroethylene membranePROCEDURE

tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket

Dense polytetrafluroethylene membrane

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
  • Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
  • Adult patients (aged 18-50 years).
  • A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.

You may not qualify if:

  • The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.
  • The presence of any local factor that may interfere with extraction as tooth ankylosis.
  • Smoking.
  • The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).
  • Subjects who had undergone radiation therapy.
  • Patients who had been subjected to or who were under bisphosphonate therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry,Alexandria University

Alexandria, Egypt

Location

Related Publications (4)

  • Landry R, Turnbell R, Howley T. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-118.

    BACKGROUND

  • Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.

    PMID: 6950834BACKGROUND

  • Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J. 1969 Aug;14(4):241-4. doi: 10.1111/j.1834-7819.1969.tb06001.x. No abstract available.

    PMID: 5259350BACKGROUND

  • Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

    PMID: 12956475RESULT

Study Officials

  • Ahmed A kamal, BDs

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 21, 2020

Study Start

March 1, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)