The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation

NCT ID: NCT04353999

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket

All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Healing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

980 nm diode laser photocoagulation

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

Group Type EXPERIMENTAL

Socket sealing by diode laser photocoagulation

Intervention Type PROCEDURE

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

Dense polytetrafluroethylene membrane

dPTFE membrane was used to seal the socket after grafting

Group Type ACTIVE_COMPARATOR

socket sealing with dense polytetrafluroethylene membrane

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Socket sealing by diode laser photocoagulation

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

Intervention Type PROCEDURE

socket sealing with dense polytetrafluroethylene membrane

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
2. Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
3. Adult patients (aged 18-50 years).
4. 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hams Hamed Abdelrahman

Assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed A kamal, BDs

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of dentistry,Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 6950834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5259350 (View on PubMed)

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.

Reference Type RESULT
PMID: 12956475 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ORG 0008839

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Soft Tissue Healing After Tooth Extraction
NCT06835543 ACTIVE_NOT_RECRUITING NA
Socket Seal Surgery
NCT06764732 COMPLETED NA